[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacokinetics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacokinetics":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,46,73,97,126,155,180,205,228,260,280,307,332,360,385,407,437,458,480,500,528,559,581,608,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443",false,"NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","18 Years","50 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[27,28,29,30,31,32],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":21},"2026-06-15",{"date":41,"type":21},"2027-05-05",{"name":43,"class":44},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100475355","phase-1-a-study-to-investigate-the-pharmacokinetics-and-ecg-effects-of-linaprazan-glurate-100475355","NCT05469854","A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate","A Phase I Trial to Investigate the Pharmacokinetics and ECG Effects of Single Doses of Linaprazan Glurate Administered as Oral Tablets to Healthy Participants","Main inclusion Criteria:\n\n1. Willing and able to give written informed consent for participation in the study.\n2. Healthy male or female aged 18 to 65 years\n3. Body mass index ≥18.5 and ≤35.0 kg\u002Fm2.\n4. Prospective subjects, as well as their partners, must agree to contraception requirements\n\nMain exclusion criteria:\n\n1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \\\u003C1%) from 2 weeks prior to dosing until the end-of-study visit.\n2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol\n3. History of or current clinically significant disease as defined in the protocol.\n4. History of GERD, significant acid reflux.\n5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).",true,"ALL","65 Years",{"count":57,"type":21},121,[24],"This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate. The trial will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses: 300 mg and 600 mg in Part I of the trial, using formulation A of linaprazan glurate, as well as 150 mg, 275 mg, and up to 2 additional dose levels, using formulation C of linaprazan glurate to reach target linaprazan mean Cmax exposure (5222 nmol\u002FL).",[31,61,62,63],"Cardiodynamic ECG","Safety, and Tolerability","GERD","RECRUITING",{"date":34,"type":37},{"date":67,"type":37},"2022-07-13",{"date":69,"type":21},"2026-11-30",{"name":71,"class":44},"Cinclus Pharma Holding AB",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":72},"100342336","phase-4-liposomal-bupivacaine-versus-plain-bupivacaine-after-intercostal-injections-for-pain-management-after-thoracoscopy-100342336","NCT03737292","Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy","Comparison of Plasma Concentration And Efficacy Of Liposomal Bupivacaine And Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy","Inclusion Criteria:\n\n1\\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:\n\n1. VATS wedge resection \u002Fsegmentectomy\n2. VATS lobectomy.\n3. Robot assisted thoracoscopic wedge resection\u002Fsegmentectomy.\n4. Robot assisted thoracoscopic lobectomy procedures.\n\nExclusion Criteria:\n\n1. Patients under18 years of age\n2. Patients weighing less than 48 kg\n3. Pregnant and lactating females will be excluded from the trial\n4. Patients preoperatively taking narcotics for chronic pain in proximity to surgical site\n5. Patients with previous ipsilateral thoracic surgery\n6. Patients undergoing pleurectomy\u002Fmechanical pleurodesis.\n7. Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon\n8. Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy)\n9. Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status\n10. Patients with hypersensitivity to local anesthetics and pain medications used in the study\n11. Patients with previous thoracic spine surgeries\n12. Patients with increased creatinine (over 1.5mg\u002Fdl)\n13. Patients with liver dysfunction\n14. Non-English speaking patients",{"count":81,"type":21},40,[83],"PHASE4","The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries.\n\nThe specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg\u002Fkg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg.\n\nThe hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng\u002FmL (2-3 mg\u002FL) at which central nervous system and cardiovascular adverse events would be expected to occur.\n\nThe secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine.\n\nAdditionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation.\n\nSignificance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery.\n\nBased on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial catheters and risks associated with them.",[86,31],"Pain, Postoperative","2026-06-10",{"date":89,"type":37},"2026-06-12",{"date":91,"type":37},"2019-04-09",{"date":93,"type":21},"2026-12",{"name":95,"class":96},"Milton S. Hershey Medical Center","OTHER",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":72},"100554569","phase-1-single-dose-study-pharmacokinetics-of-oxycodone-and-pf614-co-administered-with-nafamostat-pf614-mpar-102-100554569","NCT06500793","Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)","A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects","Inclusion Criteria:\n\n1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.\n2. Must be willing and able to comply with all study requirements.\n3. Aged 18 to 55 years, inclusive, at time of signing informed consent.\n4. Must agree to use an adequate method of contraception (as defined in Section 9.4).\n5. Healthy males or non pregnant, non lactating healthy females.\n6. Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.\n7. Minimum weight of 50 kg at screening.\n\nExclusion Criteria:\n\n1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.\n2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.\n3. Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.\n4. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease (Part 1 only: except cholecystectomy), gastrointestinal surgery (e.g. gastric bypass, gastric banding, colectomy), or neurological or psychiatric disorder, as judged by the investigator.\n5. Subjects with a history of seizures.\n6. Subjects with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.\n7. Subjects with a history of bleeding disorders or coagulopathy.\n8. Subjects with any personal history of arrhythmias or family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction prior to 50 years old).\n9. Parts 2 and 3 only: Subjects with a history of cholecystectomy or gall stones.\n10. Parts 2 and 3 only: Subjects with a history of opioid intolerance or hypersensitivity based on previous experience receiving any opioid analgesic\n11. Have poor venous access that limits phlebotomy.\n12. Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Subjects with Gilbert's Syndrome are allowed.\n13. Subjects with a platelet count \\\u003C150,000\u002FµL or international normalized ratio \\>1.1 at screening.\n14. Subjects with hemoglobin \\\u003CLLN at screening and\u002For first admission.\n15. Subjects with a QT interval corrected using Fridericia's formula (QTcF) above 450 msec at screening and\u002For first admission.\n16. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.\n17. Positive serum pregnancy test at screening or first admission. Those who are pregnant or lactating will be excluded.\n18. Subjects who have received any IMP in a clinical research study within 5 half lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days.\n19. Subjects who have previously been administered IMP in this study.\n20. Subjects who are taking, or have taken, any prescribed or over the counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or hormonal contraception) in the 14 days before study treatment administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.\n21. Subjects with an anticipated need for requiring aspirin, non-steroidal anti-inflammatory drugs, or anticoagulants in the 14 days after administration of the IMP.\n22. History of any drug or alcohol abuse in the past 2 years.\n23. Regular alcohol consumption in males \\>21 units per week and females \\>14 units per week (1 unit = 12 oz 1 bottle\u002Fcan of beer, 1 oz 40% spirit, or 5 oz glass of wine).\n24. A confirmed positive alcohol urine test at screening or first admission.\n25. Current smokers and those who have smoked within the last 12 months.\n26. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.\n27. A confirmed positive urine cotinine test at screening or first admission.\n28. Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1).\n29. Male subjects with pregnant or lactating partners.\n30. Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study treatment.\n31. Subjects who are, or are immediate family members of, a study site or sponsor employee.\n32. Failure to satisfy the investigator of fitness to participate for any other reason.","55 Years",{"count":106,"type":21},54,[24],"A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and\u002For extended-release(ER) capsule prototypes.",[31,110],"Healthy Volunteer",[112,113,114,115,116],"PF614","oxycodone","nafamostat","MPAR","overdose protection","2026-05-21",{"date":119,"type":37},"2026-05-26",{"date":121,"type":37},"2024-11-24",{"date":123,"type":21},"2027-04-28",{"name":125,"class":44},"Ensysce Biosciences",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":53,"sex":54,"minAge":133,"maxAge":104,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":72},"100637328","pharmacokinetics-of-kava-and-kratom-alone-and-in-combination-100637328","NCT07583407","Pharmacokinetics of Kava and Kratom Alone and in Combination","A Randomized, Double-Blind, 3-Period Crossover, Pharmacokinetic Study in Healthy Adults to Compare Combined Kava and Kratom Supplementation With Kava or Kratom Alone Under Fasted Conditions","Inclusion Criteria:\n\n1. Adults who are between 21 - 55 years of age (inclusive) at the time of signing the informed consent.\n2. In otherwise good general health, as deemed by the investigator (based on review of medical history, vital signs, laboratory safety tests, and physical examination performed at screening and\u002For before the first dose of study product).\n3. Are able to consume the study product completely within the specified timeframe.\n4. Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine-containing products (patches, gums, vapes, etc.), kava products, and\u002For kratom products, and willing to abstain starting 14 days prior to Visit 2 and throughout the study.\n5. Have a BMI range of 18.5 - 29.9 kg\u002Fm2 at screening and Visit 2.\n6. Agree to follow the restrictions on concomitant treatments.\n7. Agree to follow the restrictions on lifestyle.\n8. Have maintained consistent dietary habits, including supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions)\n9. Individuals with childbearing potential must agree to comply with the following requirements:\n\n   * Have a negative pregnancy test at screening and on Day 1 of each treatment period prior to administration of study product.\n   * Use a highly effective method of contraception from at least 14 days prior to the first dose through 30 days after the last dose of study product.\n10. Individuals with the potential to impregnate others must agree to use a highly effective method of contraception, from at least 14 days prior to the first dose through 30 days after the last dose of study product.\n11. Male-born participants must agree to abstain from sperm donation, and female-born participants must agree to abstain from ovum donation, from Screening through at least 30 days after the last dose of study product.\n12. Agree to abstain from alcohol consumption for 48 hours prior to, and for the entire duration of, each treatment period.\n13. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.\n14. Must have suitable veins for repeated venipuncture.\n15. Willing and able to attend video conference calls with study coordinators.\n16. Agrees not to donate blood until 3 months after study completion.\n\nExclusion Criteria:\n\n1. Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.\n2. Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.\n3. Demonstrates a positive urine drug screen test for compounds listed in Table 8 4 at the Screening Visit or Visit 2, a positive urine cotinine test at the Screening Visit or Visit 2, or a positive breath alcohol test at Screening Visit or Visit 2.\n4. Have abnormal respiratory rate (RR) or SpO2 measurements at Screening or Baseline at the discretion of the investigator.\n5. Screening laboratory results showing liver enzyme levels \\[Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin\\] ≥ 2 times the upper limit of normal (ULN), or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.\n6. Have hemoglobin below 135 g\u002FL for males or 125 g\u002FL for females, or hematocrit below 0.39 l\u002Fl for males or 0.33 l\u002Fl for females at screening.\n7. Demonstrates a positive screen for HIV at screening.\n8. Is currently enrolled in another clinical trial or has received\u002Fused an investigational product in another research study within 28 days before Visit 2.\n9. Individuals with any abnormality, obstruction, or disorder of the gastrointestinal tract that may preclude swallowing (e.g., dysphagia) or impair gastrointestinal motility, digestion, or absorption (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease \\[including Crohn's disease or ulcerative colitis\\], chronic pancreatitis, or steatorrhea). In addition, any history of gastrointestinal surgery or anatomical abnormality that, in the opinion of the Investigator, may affect the oral absorption of the study product.\n10. Have been diagnosed with Type I\u002FType II diabetes or thyroid disease\n11. High BP at the Screening Visit or Visit 2 (≥140 systolic or ≥90 diastolic mmHg)\n12. Have low BP (\\\u003C90 systolic or \\\u003C60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.\n13. Have a history of heart disease, blood-clotting disorders, renal or hepatic impairment\u002Fdisease, liver injury or any clinically significant liver or kidney disorder, as determined by the Investigator.\n14. Have known genetic polymorphisms of CYP450 enzymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2B6, and\u002For CYP3A4.\n15. Individuals with active asthma or a history of clinically significant asthma exacerbation (i.e., requiring systemic corticosteroids, emergency department intervention, or hospitalization) within the past 12 months.\n16. Individuals receiving treatment for, or who have been hospitalized in the last 12 months for, psychiatric disorders (e.g., Major Depressive Disorder, Bipolar I\u002FII, Generalized Anxiety Disorder, Schizophrenia, or other psychotic disorders), particularly when the diagnosis is established using accepted gold-standard diagnostic methods (e.g., structured clinical interviews), or with complications such as suicidal ideation or behavior.\n17. Have current use of medications, including psychiatric pharmacotherapy, that are predominantly metabolized via CYP enzymes (e.g., CYP3A4, CYP2D6, CYP1A2) and\u002For have CNS depressant or opioid-like effects, or act on central receptors such as μ- and δ-opioid, serotonergic 5-HT2A, post-synaptic alpha-2 adrenergic, or GABA receptors, where such treatment may create clinically significant pharmacokinetic or pharmacodynamic interactions with study treatments, including antidepressants, antipsychotics, mood stabilizers, anxiolytics, or benzodiazepines.\n18. Have a history of cancer with recovery occurring within 5 years prior to the Screening visit, except for localized skin cancer without metastases (e.g., completely excised basal cell carcinoma or squamous cell carcinoma of the skin) or in situ cervical cancer (e.g., adequately treated carcinoma in situ of the cervix).\n19. Reports significant blood loss or blood donation totalling between 101 mL to 449 mL of blood within 30 days before baseline or a blood donation of more than 450 mL within 90 days before Visit 2.\n20. Reports donating plasma (e.g., plasmapheresis) within 15 days before Visit 2.\n21. Major surgery in 3 months before screening or planned major surgery during the study.\n22. History of alcohol or substance abuse (e.g., opioids, kratom) (including having been hospitalized for such an in-patient or out-patient intervention program).\n23. Evidence of addictive tendency as indicated by an LDQ score ≥21.\n24. Use of anxiolytic or sleep aids (natural health products or drugs) in the 4 weeks before Visit 2.\n25. Currently consumes more than two (2) standard alcoholic beverages per day on average for 4 weeks.\n\n    Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.\n26. Excessive caffeine intake, defined as habitual consumption of \\>500 mg per day.\n27. Any other medical conditions, including active infections, or use of medications\u002Fsupplements\u002Ftherapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures, pose a significant risk to the participant or compromise the quality of study data.","21 Years",{"count":135,"type":21},18,[137],"NA","This study is being conducted to evaluate how different formulations of the Feel Free® Tonic containing Kava, Kratom, or a combination of both are processed in the body in healthy adults. The goal is to compare the pharmacokinetic profiles and safety of the combined herbal formulation with Kava alone and Kratom alone to better understand how these ingredients behave when taken individually versus together.",[140,31],"Herb-Herb Interaction",[142,143,31,144,145],"Kava","Kratom","Healthy Adults","Herbal Supplement","2026-05-08",{"date":148,"type":37},"2026-05-13",{"date":150,"type":37},"2026-05-04",{"date":152,"type":21},"2026-09-04",{"name":154,"class":44},"Botanic Tonics, LLC",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":72},"100413909","phase-4-antibiotics-as-adjuncts-to-periodontal-therapypharmacokinetic-considerations-and-dosing-strategies-100413909","NCT04669717","Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies","Pharmacokinetic Considerations and Dosing Strategies of Amoxicillin and Metronidazole or Azithromycin as Adjunct to Non-surgical Periodontal Therapy. A Randomized,6-month, Parallel-group, Clinical Trial.","AMA","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy\n* Presence of at least 30% of the teeth in the mouth with PD\\>6mm and BOP\n\nExclusion Criteria:\n\n* Persons with systemic illnesses (uncontrolled diabetes mellitus, cancer, human immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy)\n* Pregnancy or lactation\n* Persons who had taken AB within the previous 2 months\n* Persons who are taking nonsteroidal anti-inflammatory drugs\n* Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides\n* Previous periodontal therapy the last 1 year\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow due to language problems, psychological disorders, dementia, etc. of the participant\n* Participants not willing to attend regular dental maintenance visits and follow-up evaluations\n* Participation in another study with investigational drug within the 30 days preceding and during the present study","80 Years",{"count":165,"type":21},45,[83],"Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). This procedure can reduce the level of pathogenic bacteria but it can not eradicate them. In severe cases, for the complete resolution of the disease, the elimantion of certain species of bacteria is needed. In order to achieve that, the combination of different regimens of antibiotics adjunctive to the mechanical treatment has been proposed. However, dosage and duration of antimicrobial therapy should be optimal and not excessive as issues may arise related to increased antimicrobial resistance in the population and the individual due to habitual prescription of wide-spectrum antibiotic regimens, horizontal gene transfer and genetic mutation.\n\nIn the present study, in an effort to optimize the dosage and duration of the antimicrobial regimen, we will determine the pharmacokinetics (PK) and pharmacodynamic (PD) properties of the MET-AMO combination and of AZI in Gingival Crevicular Fluid (GCF), saliva and serum in severe periodontitis patients during and after either a 3-day or a 7-day course of treatment.",[169,170,31],"Periodontal Diseases","Antibiotics","2026-04-28",{"date":173,"type":37},"2026-04-29",{"date":175,"type":37},"2021-09-01",{"date":177,"type":21},"2028-12-01",{"name":179,"class":96},"University of Geneva, Switzerland",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":72},"100636012","phase-2-comparison-of-the-pharmacokinetics-pk-and-pharmacodynamics-pd-biosimilarity-of-proposed-biosimilarinterchangeable-rapid-acting-insulin-aspart-i004-and-novolog-after-single-dose-subcutaneous-administration-to-healthy-volunteers-100636012","NCT07560150","Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar\u002FInterchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers","Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar\u002FInterchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study","Inclusion Criteria:\n\n* Upon review, agree to participate and sign informed consent.\n* Healthy male and female subjects ≥ 18 to ≤ 65 years of age.\n* Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg\u002Fm2\n* Weight ≥ 50 kg.\n* Fasting plasma glucose of \\\u003C 100 mg\u002FdL (5.5 mmol\u002FL) measured with YSI at site; one repeat test is allowed.\n* HbA1c \\\u003C 5.7%.\n* Non-smoker for ≥ 3 months prior to Screening.\n* Female candidates must be \\> 1 year post-menopausal, surgically sterile, or practicing a clinically acceptable form of birth control and confirmed by negative serum pregnancy test at Screening.\n\nExclusion Criteria:\n\n* History of diabetes mellitus.\n* Resting blood pressure (BP) \\> 140\u002F90 mmHg or \\\u003C 90\u002F60 mmHg. Subjects BP may be re-checked.\n* Participation in an investigational drug\u002Fdevice study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.\n* History of any serious adverse reaction or hypersensitivity to any of the investigational product components.\n* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.\n* Subject shows evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant\u002Fanti-anxiety medication).\n* Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject (laboratory results may be re-checked once on a separate day per Investigator discretion).\n* Long QT syndrome or family history of long QT syndrome or corrected QT interval (QTcF) \\> 450 ms in men, \\> 470 ms in women at Screening.\n* Liver function test results of AST and\u002For ALT ≥ 2.5 upper normal limit (ULN)\n* Subject has a history of syncope.\n* History of any major surgery within 6 months.\n* History of any active infection, other than mild viral illness within 30 days prior to dosing.\n* History of blood clots (e.g., deep vein thrombosis or embolism) or a frequent appearance in 1st degree relatives as judged by the Investigator.\n* Known history or positive test of hepatitis B surface antigen (HBsAG), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.\n* History of systemic glucocorticoid use within 3 months before screening.\n* History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake \\> 21 units\u002Fweek (males) and \\> 14 units\u002Fweek (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU). Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL of spirits).\n* History of illicit drug abuse, including marijuana, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test at Screening.\n* Donation or loss of \\> 500 mL of blood within 56 days.\n* Chronic use of over-the-counter or prescription medication within 7 or 14 days prior to dosing (apart from vitamin\u002Fmineral supplements, occasional paracetamol, or birth control methods \\[Desogestrel is not allowed\\]).\n* Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.\n* Women who are pregnant of breast-feeding.",{"count":188,"type":21},60,[190,191],"PHASE2","PHASE3","This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.",[31,194,195],"Pharmacodynamics","Insulin Aspart","2026-04-24",{"date":198,"type":37},"2026-04-30",{"date":200,"type":37},"2026-04-06",{"date":202,"type":21},"2026-06",{"name":204,"class":44},"Amphastar Pharmaceuticals, Inc.",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":54,"minAge":212,"maxAge":17,"enrollmentInfo":213,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100436312","pkpd-of-caspofungin-in-children-severe-infection-100436312","NCT04961593","PK\u002FPD of Caspofungin in Children Severe Infection","Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection","Inclusion Criteria:\n\n* Children receiving caspofungin in pediatric intensive care unit\n\nExclusion Criteria:\n\n* No Informed Consent signed Participate in other clinical trials","3 Months",{"count":188,"type":21},"OBSERVATIONAL","Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK\u002FPD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.",[31,217],"Infection, Fungal","2026-02-12",{"date":220,"type":37},"2026-02-17",{"date":222,"type":37},"2022-10-01",{"date":224,"type":21},"2026-12-01",{"name":226,"class":96},"Children's Hospital of Fudan University",2,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":54,"minAge":4,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100548887","pediatric-antibiotic-dosing-in-extracorporal-membrane-oxygenation-padecmo-100548887","NCT06426836","Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)","Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation","PADECMO","Inclusion Criteria:\n\n* patients admitted to the pediatric intensive care unit or cardiac intensive care unit\n* patient age : 1,8 kg-15 years\n* patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)\n* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)\n* extracorporeal membrane oxygenation circuit\n\nExclusion Criteria:\n\n* no catheter in place for blood sampling\n* absence of parental\u002Fpatient consent\n* known hypersensitivity to beta-lactam antibiotics and ciprofloxacin","15 Years",{"count":238,"type":21},300,[137],"Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).",[31,242,243,244,245,246,247,248,249],"Amoxicillin-clavulanate","Piperacillin-tazobactam","Meropenem","Cefazolin","Teicoplanin","Vancomycin","Ciprofloxacin","Amikacin","2026-01-15",{"date":252,"type":37},"2026-01-16",{"date":254,"type":37},"2016-08-19",{"date":256,"type":21},"2026-07-01",{"name":258,"class":96},"University Hospital, Ghent",3,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":54,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":271,"studyType":214,"phases":4,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":72},"100244176","antibiotic-dosing-in-pediatric-intensive-care-100244176","NCT02456974","Antibiotic Dosing in Pediatric Intensive Care","ADIC","Inclusion Criteria:\n\n* patients admitted to the pediatric intensive care unit\n* patient age\u002Fweight : 1,8 kg-15 years\n* patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines\n* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)\n\nExclusion Criteria:\n\n* no catheter in place for blood sampling\n* absence of parental\u002Fpatient consent\n* known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides\n* extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )","1 Day","16 Years",{"count":270,"type":21},640,"3 Days","Pharmacokinetics of antibiotics in critically ill neonates, infants and children",[31,242,243,247,246,244,248,249],{"date":252,"type":37},{"date":276,"type":4},"2012-05",{"date":278,"type":21},"2027-09-01",{"name":258,"class":96},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100614928","phase-1-a-first-in-human-sad-and-mad-study-in-healthy-participants-to-evaluate-oral-yr011-tablet-100614928","NCT07285967","A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet","A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.","Inclusion Criteria:\n\n* Participants who meet all the following criteria could be enrolled in this study:\n\n  1. Written informed consent obtained from the participant in compliance with all local legal requirements.\n  2. Male or female participant aged between 18 and 60 years (extremes included).\n  3. Body mass index (BMI) between 18-32 kg\u002Fm2 (extremes included) and body weight less than 120 kg.\n  4. Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.\n  5. Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.\n  6. Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.\n  7. Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.\n\nExclusion Criteria:\n\n* If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:\n\n  1. Pregnant or lactating women.\n  2. Participants with dysphagia.\n  3. Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.\n  4. Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.\n  5. History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n  6. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  7. Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)\\\u003C90 mL\u002F min).\n  8. Presence of hepatic impairment: Child-Pugh A, B or C and\u002For transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels \\> ULN).\n  9. diagnosis of diabetes regardless the degree of control at screening visit\n  10. Hyperthyroidism or hypothyroidism.\n  11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.\n  12. Any major surgery within 6 months of screening.\n  13. Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I\u002FII), Treponema Pallidum antibody (positive anti-TP) at screening.\n  14. Participants with innate or acquired immune system defects.\n  15. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).\n  16. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.\n  17. Participant has a QT interval with Fridericia's correction method (QTcF) \\>450 ms (males) or\\>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT\u002FQTc interval.\n  18. Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.\n  19. Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal \\[including traditional Chinese medicinal products\\] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration. etc.","60 Years",{"count":289,"type":21},64,[24],"This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.\n\nThe trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.\n\nKey procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.\n\nThe trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.",[29,30,31],[294,295,296,297],"KV1.3","YIRUI pharma","yirui","Healthy Volunteers","2025-12-18",{"date":300,"type":37},"2025-12-26",{"date":302,"type":21},"2026-04-01",{"date":304,"type":21},"2026-12-31",{"name":306,"class":44},"Hangzhou Yirui Pharmaceutical Technology Co., Ltd",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":72},"100572469","phase-1-safety-and-pk-of-ceftibuten-ledaborbactam-etzadroxil-fixed-dose-combination-100572469","NCT06733675","Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination","A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil","Inclusion Criteria:\n\n* Healthy adult male or female, between 18 and 55 years of age\n* Body mass index ≥ 18 and ≤ 32 kg\u002Fm2\n* Laboratory values meeting defined laboratory ranges\n* Males or non-pregnant, non-lactating females\n\nExclusion Criteria:\n\n* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug\n* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant\n* Positive alcohol, drug or tobacco use\u002Ftest",{"count":315,"type":21},46,[24],"This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.",[110,31,29,319,320],"Drug-Drug Interaction (DDI)","FDC",[297,322,323],"Ceftibuten","Ledaborbactam etzadroxil","2025-12-17",{"date":298,"type":37},{"date":327,"type":37},"2025-01-07",{"date":329,"type":21},"2026-06-30",{"name":331,"class":44},"Basilea Pharmaceutica",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":72},"100573887","phase-1-safety-tolerability-and-pharmacokinetics-of-rcs-21-in-healthy-volunteers-100573887","NCT06752122","Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.","Safety, Tolerability and Pharmacokinetics of Single-ascending Doses of RCS-21 in Healthy Volunteers. A Double Blind, Randomized, Placebo Controlled Phase I Study.","AMIR-21","Inclusion Criteria:\n\n1. Able and willing to give written informed consent.\n2. Male or female aged 18 to 64 years (inclusive).\n3. Women will be considered for inclusion if they are:\n\n   * Not pregnant, as confirmed by pregnancy test (see assess- ment schedule), and not breastfeeding. AND\n   * WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly\n\n     * according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 30 days after the last administration of study medication:\n\n       * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * intravaginal\n         * transdermal\n       * progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n         * oral\n         * injectable\n         * implantable\n       * intrauterine device (IUD)\n       * intrauterine hormone-releasing system (IUS)\n       * bilateral tubal occlusion\n       * vasectomized partner (provided that this partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical as- sessment of the surgical success)\n       * sexual abstinence (defined as refraining from hetero- sexual intercourse during the entire study period, be- ginning 2 weeks prior to the screening visit) OR\n   * Of non-childbearing potential defined according to the Clinical Trial Facilitation Group (CTFG) document \"Recommendations related to contraception and pregnancy testing in clinical trials\"\n4. Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 30 days after the last administra- tion of study medication:\n\n   * Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.\n   * Male participants are required to use a condom during treatment and until 30 days after the last administration of study medication.\n   * Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 30 days after the last administration of study medication.\n   * Sperm donation is not allowed during treatment and until 30 days after the last administration of study medication.\n5. Healthy participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead Electrocardiogram (ECG), pulmonary function testing and clinical laboratory tests.\n6. Body Mass Index (BMI) of 18.5 to 31.9 kg\u002Fm2 (inclusive).\n7. Ability to inhale in an appropriate manner (e.g. as confirmed in the inhalation training using the PARI eFlow® device with a pla- cebo medication at the screening visit).\n8. Non-smokers (including e-cigarette) or ex-smokers (with less than 10 pack years and stopped smoking for at least 5 years prior to screening visit).\n9. Normal pulmonary function with Forced Expiratory Volume in the first second (FEV1) ≥ 80 % of predicted normal at screening visit. Calculations will be based on the Global Lung Function Initiative (GLI 2012) formula.\n\nExclusion Criteria:\n\n1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study or may influence the results of the study, or the participant's ability to participate in the study.\n2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, he- patic disease (asymptomatic Gilbert syndrome is allowed), renal disease, hematological disease, neurological disease, endo- crine disease (stable and asymptomatic hypothyroidism with or without Hormone Replacement Therapy (HRT) is allowed) or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).\n3. Having received any vaccination within the last 2 weeks before the first screening visit.\n4. History or current evidence of clinically relevant allergies or idiosyncrasy to any drug or food.\n5. History of allergic reactions to any active or inactive component of the study medication (including medication for bronchoscopy, e.g. salbutamol, lidocaine, midazolam or propofol).\n6. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).\n7. Proneness to orthostatic dysregulation, fainting, or blackouts.\n8. History or presence of any malignancy except for basalioma.\n9. Chronic or acute infections or history of an acute infection during the four weeks before the first screening visit.\n10. Positive results in any of the following virology tests: human im- munodeficiency virus (HIV) antibodies and antigen, Anti-hepati- tis B-core antibody (HBc-Ab), hepatitis B-surface antigen (HBs- Ag) and anti-hepatitis C virus antibody (HCV-Ab).\n11. Positive drug screen (amphetamines, barbiturates, benzodiaze- pines, cannabinoids, cocaine, methadone, methamphetamine, opiates, phencyclidine, or tricyclic antidepressants).\n12. History of previous administration of any registered or investiga- tional oligonucleotide-based drug.\n13. History or presence of alcohol or drug abuse.\n14. Use of any medication (including over-the-counter medication, herbal products) except allowed concomitant medication within 2 weeks (for biologics: 6 months) before administration of IMP or within \\< 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer.\n15. Positive breath alcohol test.\n16. Planned donation of oocytes, blood, organs, bone marrow dur- ing the course of the study or within 6 months after the last screening visit.\n17. Participation in another clinical study with an investigational drug or device within the last 3 months or during the course of the study. For biologics, the minimum exclusion period is at least 6 months or the time of duration of the pharmacodynamic effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this study.\n18. Blood donation of more than 250 ml within the last 30 days before the first screening visit.\n19. Anticipated non-availability for study visits\u002Fprocedures.\n20. Anticipated lack of willingness or inability to cooperate adequately.\n21. Vulnerable participants, except WOCBP.","64 Years",{"count":342,"type":21},24,[24],"The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose of RCS-21 and their health status will be constantly monitored.",[297,29,30,31],[347,348,349,350],"RCS-21","Phase I","Healthy volunteers","Inhalation","2025-11-17",{"date":353,"type":37},"2025-11-20",{"date":355,"type":37},"2025-02-18",{"date":357,"type":21},"2026-08",{"name":359,"class":44},"RNATICS GmbH",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":53,"sex":54,"minAge":133,"maxAge":104,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":72},"100582162","phase-1-high-potency-cannabis-acute-and-protracted-effects-100582162","NCT06859723","High Potency Cannabis: Acute and Protracted Effects","HIGH-CAP","Inclusion Criteria:\n\n* • Male or non-pregnant and non-lactating females aged 21-55 years\n\n  * Report cannabis smoking near daily\n  * Not currently seeking treatment for their cannabis use\n  * Have a Body Mass Index from 18.5 - 34kg\u002Fm2.\n  * Able to perform all study procedures\n  * Must be using a contraceptive (hormonal or barrier methods)\n\nExclusion Criteria:\n\n* Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine\n* Do not have positive urine toxicology for cannabis use during screening\n* Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.\n* Report using other illicit drugs in the prior 4 weeks\n* Current predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes\n* Current pain\n* Pregnancy\n* Currently enrolled in another research protocol\n* Not using a contraceptive method (hormonal or barrier methods)\n* Insensitivity to the cold water stimulus of the Cold Pressor Test\n* Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.\n* Not able to speak and read English",{"count":20,"type":21},[24],"The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.",[371,372,31],"Abuse Cannabis","Pain",[374,375],"THC","Cannabis","2025-09-30",{"date":378,"type":37},"2025-10-06",{"date":380,"type":37},"2025-07-03",{"date":382,"type":21},"2028-07-01",{"name":384,"class":96},"University of California, Los Angeles",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100450215","phase-1-phase12a-study-for-ipg7236-in-patients-with-advanced-solid-tumors-100450215","NCT05142592","Phase1\u002F2a Study for IPG7236 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. A written informed consent must be signed prior to performing any study procedures.\n2. Male or females 18 years or older.\n3. Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.\n\n   * Part 1 Dose Escalation: all solid tumor types.\n   * Part 2 Dose Expansion: the following tumor types are tentatively planned for expansion. It may be modified based on the results from the dose escalation phase.\n\n     * Renal cancer\n     * Triple-negative breast cancer\n     * Head and neck cancer\n     * Melanoma\n4. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds.\n5. Subjects must demonstrate measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n6. Subjects must have a life expectancy of ≥ 3 months.\n7. Subjects must have an Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1.\n8. Subjects must have adequate hematologic and organ function as indicated by the following laboratory values\n\n   1. Hematologic\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n      * Platelet count ≥ 100×109\u002FL\n      * Hemoglobin ≥ 9 g\u002FdL (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g\u002FdL)\n   2. Renal\n\n      • Estimated glomerular filtration rate（eGFR ）≥ 50 mL\u002Fmin OR serum creatinine ≤ 1.5 × upper limit of normal (ULN).\n   3. Hepatic\n\n      * Aspartate aminotransferase levels ≤ 3 ×ULN (if liver metastases are present, ≤ 5× ULN)\n      * Alanine aminotransferase levels ≤ 2.5 × ULN (if liver metastases are present, ≤ 5×ULN).\n      * Bilirubin ≤ 1.5 × ULN\n   4. Coagulation • Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN\n9. Subjects must be able to swallow and retain orally administered medication.\n10. Patients must be willing and able to comply with all scheduled visits, treatment, laboratory tests, be able to take oral medication, and other requirements of the study\n11. Female patients of child-bearing potential must have a negative pregnancy test.\n12. Female patient who is of child-bearing potential is eligible to participate but must use an acceptable form of birth control method, including abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), diaphragm with spermicide, cervical cap, condoms with contraceptive gel\u002Ffoam \u002Fcream, or surgical sterilization (tubal ligation at least 6 months prior to screening) or partner who had a vasectomy at least 6 months prior to screening\n13. Male patient with a female partner of child-bearing potential is eligible to participate but must be either documented to be surgically sterile (vasectomy), practicing complete abstinence for 90 days after study drug administration, or using two adequate forms of highly effective contraception (together with the female partner), one of which should be a physical barrier method, for 90 days after the study drug administration.\n\nExclusion Criteria:\n\n1. Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.\n2. Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.\n3. Subjects with recent prior therapy defined as\n\n   1. Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.\n   2. Any radiotherapy, chemotherapy, targeted therapy or immunotherapy within 14 days or major surgery within 28 days or anti-neoplastic antibody or nitrosoureas\u002Fmitomycin C within 42 days prior to the first dose of study drug\n4. Subjects with any uncontrollable diseases (e.g., severe mental, neurological, cardiovascular, respiratory, and other systemic diseases) or obvious active infections that may affect the clinical study.\n5. Subjects with positive Coronavirus disease（COVID）-19 PCR tests (patients who recovered from COVID-19 but have positive COVID-19 PCR tests may be included at the judgment of the Investigator)\n6. Subjects who have received the live or attenuated vaccine within 4 weeks prior to study treatment or intend to receive a live or attenuated vaccine during the study\n7. Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment. History of known HIV infection.\n\n   Note:\n   1. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) is obtained.\n   2. Subjects with well-controlled HIV may be enrolled if all the following criteria are met:\n\n      * must be stable on their anti-retroviral regimen, and participants must be healthy from an HIV perspective\n      * Participants must have a cluster of differentiation 4（CD4） count of greater than 250 cells\u002Fmicro litre（mcL ）over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FmcL over the past 2 years unless it was deemed related to THE CANCER AND\u002FOR CHEMOTHERAPY-induced bone marrow suppression\n\n        \\- For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FmcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n      * Participants must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FmcL within 7 days of enrollment\n      * Participants must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts\n8. Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent may be included at the judgment of the Investigator.\n9. Subjects with symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for \\>1 month, are asymptomatic and off corticosteroids, or are on a stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. The stability of brain metastases must be confirmed with imaging. The subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post procedure complications or the subject is stable.\n10. Subjects with active upper digestive tract ulcer or other disorders that can affect drug absorption, distribution, metabolism or clearance.\n11. Subjects with a marked baseline prolongation of QT\u002Fcorrected QT interval（QTc） interval (e.g., repeated demonstration of a QTc interval \\>480 milliseconds (CTCAE grade 1) using Fridericia QT correction formula.\n12. Subjects using concomitant medications known to prolong the QT\u002FQTc interval.\n13. Pregnancy or breastfeeding female; Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.\n14. Subjects who are unable to comply with study and follow-up procedures",{"count":393,"type":21},196,[24,190],"This is a Phase 1\u002F2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.\n\nThe study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).\n\nEach part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.",[397,30,31],"Safety Issues","2025-09-22",{"date":400,"type":37},"2025-09-24",{"date":402,"type":37},"2021-11-15",{"date":404,"type":21},"2025-12-21",{"name":406,"class":44},"Nanjing Immunophage Biotech Co., Ltd",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":53,"sex":415,"minAge":17,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":423,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":227},"100597570","phase-1-food-effect-on-pk-of-dw-1021-pelubiprofen-45-mg--tramadol-459-mg-in-healthy-adults-100597570","NCT07060209","Food Effect on PK of DW-1021 (Pelubiprofen 45 mg \u002F Tramadol 45.9 mg) in Healthy Adults","A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg \u002F Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions","DW-1021F","Inclusion Criteria:\n\n1. Healthy male subjects aged 20 to 40 years at screening visit\n2. Body Mass Index (BMI) between 18.5 and 24.9 kg\u002Fm²\n3. Body weight greater than 50 kg\n4. Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg\n5. Regular heart rate ranging from 60 to 90 beats per minute\n6. No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases\n7. Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV\u002FAIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal range or, if outside the normal range, not clinically significant as judged by the investigator\n8. Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects\n9. Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs\n\nExclusion Criteria:\n\n1. Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration\n2. Participation in any other clinical trial within 3 months prior to screening\n3. Blood donation within 8 weeks prior to drug administration\n4. History of gastrointestinal surgery that may affect drug absorption\n5. History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation\n6. Known hypersensitivity or allergy to the test or reference drug or their components\n7. Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products\n8. Suffering from dysphagia","MALE","45 Years",{"count":418,"type":21},14,[24],"This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.",[297,31,422],"Food Effect in Healthy Volunteers",[424,425,426,427],"Pelubiprofen","DW-1021","Tramadol","Food effect","2025-08-22",{"date":430,"type":37},"2025-08-28",{"date":432,"type":21},"2025-09-20",{"date":434,"type":21},"2025-11-25",{"name":436,"class":96},"Haiphong University of Medicine and Pharmacy",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":72},"100581237","phase-1-single-ascending-dose-and-multiple-ascending-dose-study-of-avr-48-100581237","NCT06847698","Single Ascending Dose and Multiple Ascending Dose Study of AVR-48","Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form (ICF).\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Healthy adult male or female, aged 18 to 55, inclusive, at Screening.\n4. Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study\n5. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg\u002Fm2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening.\n6. Medically healthy with no clinically significant abnormalities in medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.\n7. If female of childbearing potential, must be consistently using an effective method of contraception from screening visit until 30 days after the last drug administration.\n8. If female and not of childbearing potential, must be either surgically sterile or post menopausal (i.e., more than 1 year since last menstrual period).\n9. A non-vasectomized, male subject must agree to use an effective method of birth control with female partners of childbearing potential during the study and to refrain from donating sperm for 90 days following dosing.\n10. No restrictions are required for a vasectomized male subject provided his vasectomy has been performed 4 months or more (and have official documentation) prior to Study Day 1. A subject who has been vasectomized less than 4 months prior to Study Day 1 or does not have official documentation of his vasectomy must follow the same restrictions as a non-vasectomized subject.\n\nExclusion Criteria:\n\n1. Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n5. Has had surgery or any medical condition within 6 months prior to first dosing which may affect the distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.\n6. Female subjects with a positive pregnancy test or who are lactating.\n7. Positive urine drug or alcohol results at screening or first check-in.\n8. Positive cotinine results at screening.\n9. Positive result at screening for tuberculosis (i.e., positive result for QuantiFERON TB-Gold).\n10. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n11. Unable to refrain from or anticipates the use of:\n\n    • Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Hormone replacement therapy will be allowed.\n12. Donation or loss of 50 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days prior to the first dosing.\n13. Plasma donation within 14 days prior to the first dosing.\n14. Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.\n15. Had a treatment with other investigational drug within 5 times the terminal elimination half-life (t1\u002F2), if known (e.g., a marketed product) or within 30 days (if the t1\u002F2 is unknown), whichever is longer, prior to Study Day 1 dosing.\n16. Evidence of Coronavirus Disease 2019 (COVID-19) infection.",{"count":445,"type":21},48,[24],"This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.",[397,30,31,194],"2025-04-03",{"date":451,"type":37},"2025-04-06",{"date":453,"type":21},"2025-06",{"date":455,"type":21},"2025-11",{"name":457,"class":44},"AyuVis Research, Inc.",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":53,"sex":54,"minAge":465,"maxAge":55,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100586499","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-ag2304-compared-to-coadministration-of-ag23041-and-ag23042-100586499","NCT06916169","A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042","An Open-label, Randomized, Fasting, Single, Group 2, Stage 2, Cross-over Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 in Healthy Adult Volunteers","Inclusion Criteria:\n\n* A healthy adults aged 19-65 years at the time of screening\n* Subjects who are deemed eligible based on the screening tests\n\nExclusion Criteria:\n\n* Subjects who have taken the investigational drug within 6 months prior to the first dose\n* Other exclusions have been applied","19 Years",{"count":467,"type":21},70,[24],"The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.",[31],"2025-04-02",{"date":473,"type":37},"2025-04-08",{"date":475,"type":21},"2025-08",{"date":477,"type":21},"2025-09",{"name":479,"class":44},"Ahn-Gook Pharmaceuticals Co.,Ltd",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":53,"sex":415,"minAge":17,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":72},"100560204","phase-1-relative-bioavailability-of-two-orally-administered-cbd-formulations-in-healthy-male-adults-100560204","NCT06574100","Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults","Inclusion Criteria:\n\n1. Age 18 - 35 years old\n2. Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.\n3. No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.\n4. Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.\n5. Ability to return for blood draws in the subsequent days.\n\nExclusion Criteria:\n\n1. History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.\n2. History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure\n3. Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)\n4. Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.\n5. Personal or family history of schizophrenia or any other psychotic disorder\n6. Current or past drug or alcohol dependence or abuse\n7. Use of Cannabis-based therapy within 2 months (Participants who have previously used a Cannabis-based therapy may be included if they have a 2-month period without use of Cannabis-based therapy prior to enrolment in the study)\n8. Use of recreational Cannabis within 2 months (Participants who have previously used recreational Cannabis may be included if they have a 2-month period without use of recreational Cannabis prior to enrolment in the study)\n9. Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week\n10. Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week\n11. Use of any other medication known to interact with medicinal Cannabis within one week.\n12. Allergy or known intolerance to any of the compounds within the study preparation.\n13. Resting heart rate HR \\\u003C 50 bpm or \\> 100 bpm or seated blood pressure \\\u003C 100\u002F60 or higher than 140\u002F90\n14. Inability of study participants to attend and complete all study visits\n15. Bleeding disorder\n16. Known low hematocrit","35 Years",{"count":488,"type":21},20,[24],"This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.",[31],"2025-03-25",{"date":494,"type":37},"2025-03-30",{"date":496,"type":37},"2024-10-26",{"date":455,"type":21},{"name":499,"class":96},"University of Saskatchewan",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":72},"100340829","phase-4-posaconazole-pharmacokinetics-in-patients-receiving-chemotherapy-or-stem-cell-transplants-100340829","NCT03717623","Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants","Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection","POPULAR","Inclusion Criteria:\n\n* Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Unable to give informed consent.",{"count":509,"type":21},100,[83],"The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.",[513,31,514,515,516,517,518],"Posaconazole","Invasive Candidiases","Invasive Aspergillosis","Invasive Mycosis","Fungal Infection","Prophylaxis","2025-02-26",{"date":521,"type":37},"2025-02-28",{"date":523,"type":37},"2019-08-01",{"date":525,"type":21},"2025-12-30",{"name":527,"class":96},"Melbourne Health",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":416,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":537,"conditions":538,"keywords":541,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":72},"100566111","early-phase-1-pharmacokinetics-of-oral-calcium-carbonate-in-parturients-100566111","NCT06650930","Pharmacokinetics of Oral Calcium Carbonate in Parturients","Inclusion Criteria:\n\n* Pregnant female subjects at the study institution, admitted for labor (spontaneous, augmented, or induced)\n\nExclusion Criteria:\n\n1. severe range blood pressure (BP \\>160\u002F\\>110) within the 48 hours prior to delivery\n2. patient age \\\u003C18 years or \\>45 years\n3. renal dysfunction with a documented serum Cr \\> 1.0 mg\u002FdL\n4. known history of congenital or acquired cardiac disease or history of arrhythmia\n5. patient taking digoxin\n6. patient currently taking a calcium channel blocker\n7. Weight \\\u003C55kg or \\>100kg, or\n8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery\n9. Prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment\n10. Patient took a calcium supplement in the past 48 hours\n11. Patient status is NPO (nothing by mouth) as ordered by the clinical team",{"count":188,"type":21},[536],"EARLY_PHASE1","This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as \"Tums\"). This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.",[539,31,540],"Pregnancy","Postpartum Hemorrhage",[542,543,544,545,546,547,548,549],"calcium","oral calcium","calcium carbonate","calcium pharmacokinetics","pharmacokinetics in pregnancy","postpartum hemorrhage","ionized calcium","pharmacokinetics","2024-11-16",{"date":552,"type":37},"2024-11-20",{"date":554,"type":21},"2025-01",{"date":556,"type":21},"2025-10",{"name":558,"class":96},"Stanford University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100567346","real-world-pharmacokineticpharmacodynamic-study-of-eravacycline-in-critically-iii-patients-100567346","NCT06666998","Real-World Pharmacokinetic\u002FPharmacodynamic Study of Eravacycline in Critically III Patients","Inclusion Criteria:\n\n* Adult male or female aged 18-75 years\n* Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration\n* Empirical antimicrobial treatment is ineffective\n* Eravacycline application for ≥ 3 days\n* Understand and sign informed consent\n\nExclusion Criteria:\n\n* Urinary tract infection\n* Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions\n* Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient\n* Patients expected to survive for no longer than 48h.","75 Years",{"count":509,"type":21},"The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.",[569,31,570,571,572],"Eravacycline","Bacteria Infection","Bacterial Resistance to Antimicrobial","Empirical Antimicrobial Therapy","2024-11-01",{"date":575,"type":37},"2024-11-04",{"date":573,"type":21},{"date":578,"type":21},"2026-11-01",{"name":580,"class":96},"Sichuan Provincial People's Hospital",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":72},"100332304","phase-1-mdma-in-subjects-with-moderate-hepatic-impairment-and-subjects-with-normal-hepatic-function-100332304","NCT03606538","MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function","A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function","Inclusion Criteria:\n\n* Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).\n* Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.\n* Age 18 to 65 years.\n* Weight \\> 45 kg\n* Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.\n* Negative urine test for drugs of abuse at Screening and prior to trial drug administration.\n* Able to comprehend and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Have a current psychiatric diagnosis.\n* Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.\n* Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and\u002For laboratory signs of hepatic impairment within 2 weeks.\n* Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.\n* Have spontaneous bacterial peritonitis within 3 months prior to screening.\n* Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis)\n* Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration.\n* For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment.\n* For control participants only: have clinically significant laboratory results outside the normal limits, including AST \\>48 U\u002FL, ALT \\> 55 U\u002FL, GGT \\> 48 U\u002FL, bilirubin \\> 1.2 mg\u002FdL or hemoglobin \\\u003C 12 g\u002FdL.\n* Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject.\n* Have any positive test for drugs of abuse and \u002For alcohol at screening.\n* Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \\> 450 ms in men, \\> 470 ms in women on the screening ECG.\n* Have a PR interval \\> 240 ms, QRS \\> 110 ms or a history of prolongation of QT interval.\n* Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation.\n* Are unwilling to stay in the clinical unit for the required duration as per the protocol.\n* Have a known or suspected allergy to trial product or related products.",{"count":589,"type":21},16,[24],"The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.\n\nThe main questions it aims to answer are:\n\nDo people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?\n\nResearchers will compare people with abnormal liver function to people with normal liver function.\n\nParticipants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.",[31,593],"Hepatic Impairment",[595,596,597,598],"MDMA","metabolism","methylenedioxymethamphetamine","midomafetamine","2024-10-28",{"date":601,"type":37},"2024-10-30",{"date":603,"type":21},"2026-03-29",{"date":605,"type":21},"2028-12",{"name":607,"class":44},"Resilient Pharmaceuticals",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":53,"sex":54,"minAge":17,"maxAge":104,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":72},"100545288","phase-1-drug-drug-interaction-ddi-study-of-leramistat-in-healthy-adult-subjects-100545288","NCT06379958","Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects","A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects","Principal Inclusion Criteria:\n\nHealthy, adult, male or female of non childbearing potential 18 to 55 years of age.\n\nPrincipal Exclusion Criteria:\n\nHistory or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n\nHistory of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.",{"count":445,"type":21},[24],"A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.",[31],"2024-08-08",{"date":621,"type":37},"2024-08-09",{"date":623,"type":37},"2024-04-08",{"date":625,"type":21},"2024-09-30",{"name":627,"class":44},"Modern Biosciences Ltd",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":634,"targetDuration":635,"studyType":214,"phases":4,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":72},"100326406","pharmacokinetics-of-liposomal-amphotericin-b-in-critically-ill-vs-non-critically-ill-hematological-patients-exploration-of-covariates-100326406","NCT03529617","Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates","Inclusion Criteria:\n\n* Treatment with L-AmB\n* Admitted to an ICU or Hematology ward\n\nExclusion Criteria:\n\n* DNR 2 or 3\n* Pregnant or lactating women\n* Previous documentation of intolerance\u002Fsensitivity to L-AmB",{"count":188,"type":21},"1 Month","This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.",[31,638,639],"Liposomal Amphotericin B","Critically Ill Patients","2024-07-02",{"date":642,"type":37},"2024-07-03",{"date":644,"type":37},"2016-10-19",{"date":646,"type":21},"2025-12-31",{"name":648,"class":96},"Universitaire Ziekenhuizen KU Leuven"]