[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-adult-subject\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-adult-subject":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,67,90,111,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100638960","phase-1-a-study-of-hdm1002-tablets-on-cardiac-repolarization-in-healthy-subjects-100638960",false,"NCT07594847","A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects","A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects","Inclusion Criteria:\n\n* The subject has voluntarily signed a written informed consent form.\n* Male or female; age between 18 and 45 years (inclusive).\n* Subject's weight ≥50 kg, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm2, inclusive. BMI = weight (kg) \u002F height2 (m2).\n* Medical history inquiry, physical examination, laboratory test items, and other trial-related tests at screening are all normal or show mild abnormalities with no clinical significance, and the subject is judged to be eligible by the clinical research physician.\n* The subject is able to communicate well with the investigator and comply with the protocol requirements to complete the study.\n\nExclusion Criteria:\n\n* History of or current neurological\u002Fpsychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, or musculoskeletal system diseases, hepatic or renal insufficiency, or any other disease or physiological condition that may affect the study results;\n* Subjects with a personal or family history of medullary thyroid cancer (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2);\n* History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening;\n* History of a cholecystitis episode within 3 months prior to screening;\n* History of allergy to HDM1002, moxifloxacin hydrochloride tablets, other fluoroquinolones or quinolones, or any of the excipients; or history of food allergy, or a specific allergy history (asthma, urticaria, eczema, etc.);\n* Clinically significant major illness or undergone major surgery within 3 months prior to the trial;\n* Blood donation within 3 months, or plans to donate blood during this study, or transfusion or blood loss ≥200 mL within 4 weeks prior to the trial;\n* Has consumed a special diet, engaged in strenuous exercise, or had other factors that affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to dosing;\n* Pregnant or lactating, or has a positive blood pregnancy test result;\n* The investigator believes that the subject has any other condition that makes them unsuitable for participation in this clinical trial.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT\u002FQTc interval in healthy subjects.",[28],"Healthy Adult Subject","RECRUITING","2026-05-17",{"date":32,"type":33},"2026-05-19","ACTUAL",{"date":35,"type":33},"2026-03-07",{"date":37,"type":22},"2026-11-06",{"name":39,"class":40},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100619211","phase-1-a-single-center-randomized-open-label-parallel-design-clinical-study-to-evaluate-the-pharmacokinetic-effects-of-itraconazole-fluconazole-or-efavirenz-on-a-single-dose-of-clifutinib-in-healthy-participants-100619211","NCT07341672","A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants","The Drug-Drug Interaction Study of Clifutinib","Inclusion Criteria:\n\n1. Informed consents were signed voluntarily with full understanding of the trial content, process and possible adverse reactions. Be able to complete the trial according to the requirements of the trial protocol.\n2. Have no plans of fertility, sperm retrieval or egg donation during the trial, and are willing to take effective contraceptive measures within 6 months from the date of signing ICF to the end of drug administration.\n3. Male or female participants aged 18 to 50 years old (including 18 and 50 years old).\n4. Male participants weighed at least 50 kg and female participants weighed at least 45 kg. Body mass index (BMI) = weight (kg)\u002Fheight2 (m2), with BMI in the range of 18 to 28 kg\u002Fm2 (including cutoff).\n\nExclusion Criteria:\n\n1. During the screening period, physical examination, vital signs, laboratory tests(blood routine, blood biochemistry, coagulation function, urine routine), chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), ophthalmic examination and other examinations were abnormal and had clinical significance.\n2. QTcF was calculated with Fridericia's correction formula QTcF = QT\u002FRR (RR\\^0.33=60\u002F heart rate (BPM)) in patients with abnormal 12-lead electrocardiogram (ECG) or corrected QT interval (QTcF) \\>450 ms.\n3. Any positive of hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or treponema pallidum antibody.\n4. The female participants were pregnant or lactating, and the blood pregnancy results at screening and admission exceeded the upper limit of the normal value.\n5. Taking any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 14 days before screening.\n6. Taking any drugs that alter liver enzyme activity, such as barbiturates, rifampicin, within 30 days before screening.\n7. Taking an inhibitor or inducer of CYP3A4 within 30 days before screening.\n8. Were enrolled in a clinical trial of any drug within 3 months before screening and used a trial drug, or were planning to enroll in another clinical trial during the trial.\n9. Received a vaccination within 28 days before screening or planned to be vaccinated during the trial.\n10. Blood donation or blood loss \\>450 mL within 3 months before screening; Or planned to donate blood during the trial.\n11. Patients with dysphagia or a gastrointestinal, hepatic, or renal disease (whether cured or not) within 6 months before screening that can affect drug absorption or excretion.\n12. Suffering from any condition that increases the risk of bleeding, such as active hemorrhoids bleeding, acute gastritis or gastric and duodenal ulcers.\n13. Patients with past or present serious or chronic diseases of digestive system, urinary system, respiratory system, circulatory system, nervous system, blood system, endocrine system, immune system, mental system, etc.\n14. Acute illness or concomitant medication occurred from the date of signing the informed consent to the date of first administration of the investigational drug.\n15. Allergic constitution (multiple drugs and food allergy), allergic to Clifutinib or any drug component, allergic to itraconazole, fluconazole and efavirenz or any drug component.\n16. The average daily smoking was more than 5 cigarettes in the 3 months before the trial, or the habitual use of nicotine-containing products, and could not quit during the trial.\n17. If they had a history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or were unable to abstain from alcohol during the study period, or had an alcohol breath test result greater than 0 mg per 100 mL.\n18. Those with a positive urine drug screen or who had a history of drug abuse or drug use in the past 5 years.\n19. Ingested chocolate, any caffeinated or xanthine-rich food or drink within 24 hours before taking the test drug, or were unable to stop taking it during the trial.\n20. Had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 14 days before screening, or could not stop taking special diet or strenuous exercise during the trial; Or other factors affecting drug absorption, distribution, metabolism and excretion as judged by the researchers.\n21. Those who have special requirements for diet and cannot accept a uniform diet.\n22. Those who had a history of faintness in needles or blood, who had difficulty in blood collection or could not tolerate blood collection by venipuncture, or who had poor evaluation of venous blood collection.\n23. Participants were deemed by the investigator to be ineligible for the trial for any reason.","50 Years",{"count":51,"type":22},80,[25],"Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.",[28],[56],"Clifutinib","NOT_YET_RECRUITING","2026-04-24",{"date":60,"type":33},"2026-04-27",{"date":62,"type":22},"2026-12-31",{"date":64,"type":22},"2027-05-08",{"name":66,"class":40},"Sunshine Lake Pharma Co., Ltd.",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":41},"100562835","phase-1-a-relative-bioavailability-and-food-effect-study-of-hdm1002-in-healthy-subjects-100562835","NCT06608329","A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects","A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects","Inclusion Criteria:\n\n1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.\n2. Age range of 18-45 years old (including range), no limit to gender.\n3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg\u002Fm2 (including cut-off values).\n4. Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.\n\nExclusion Criteria:\n\n1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng\u002FL during the screening period.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n3. History of acute cholecystitis attack within 3 months prior to screening.\n4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.\n5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.\n6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .\n7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.\n8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.\n9. Presence of clinically significant ECG results judged by the investigator at screening.",{"count":75,"type":22},33,[25],"The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.",[28],[80,81],"HDM1002 tablet","Glucagon-Like Peptide-1 Receptor Agonists","2024-09-20",{"date":84,"type":33},"2024-09-23",{"date":86,"type":22},"2024-10",{"date":88,"type":22},"2024-12",{"name":39,"class":40},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":41},"100562311","phase-1-a-drug-drug-interaction-ddi-study-of-hdm1002-with-repaglinide-atorvastatin-digoxin-and-rosuvastatin-in-healthy-subjects-and-overweight-subjects-100562311","NCT06601517","A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.","A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight Adult Chinese Subjects","Inclusion Criteria:\n\n1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.\n2. Age range of 18-45 years old (including range), no limit to gender.\n3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg\u002Fm2 (including cut-off values).\n\nExclusion Criteria:\n\n1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng\u002FL during the screening period.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n3. History of acute cholecystitis attack within 3 months prior to screening.\n4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.\n5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.\n6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .\n7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.\n8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.\n9. Presence of clinically significant ECG results judged by the investigator at screening.",{"count":98,"type":22},30,[25],"The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.",[28,102],"Overweight Subject",[104,81],"HDM1002","2024-09-19",{"date":84,"type":33},{"date":86,"type":22},{"date":109,"type":22},"2025-04",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":16,"sex":118,"minAge":18,"maxAge":19,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":41},"100560381","phase-1-a-study-to-characterize-mass-balance-of-14c-hdm1002-in-chinese-healthy-subjects-100560381","NCT06576401","A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects","A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects","Inclusion Criteria:\n\n1. Male, healthy adult;\n2. Age of 18 to 45 years old (both inclusive);\n3. Body mass index (BMI) between 19.0- 32.0 kg\u002Fm2 (both inclusive) and body weight no less than 50.0 kg.\n\nExclusion Criteria:\n\n1. Clinically significant diseases at the time of screening;\n2. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng\u002FL during the screening period;\n3. History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;\n4. History of acute cholecystitis attack within 3 months prior to screening;\n5. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;\n6. Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;\n7. Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;\n8. Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;\n9. History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;\n10. Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen\u002Fantibody combination test (HIV-Ag\u002FAb) and Treponema pallidum antibody during the screening period.\n11. Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest\u002Fabdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;","MALE",{"count":120,"type":22},10,[25],"In this study, a single dose of \\[14C\\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \\[14C\\] HDM002.",[28],[104,81],"2024-09-03",{"date":127,"type":33},"2024-09-04",{"date":129,"type":33},"2024-08-27",{"date":88,"type":22},{"name":39,"class":40},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":41},"100559281","phase-1-a-drug-drug-interaction-ddi-study-of-hdm1002-with-rifampicin-and-itraconazole-in-healthy-subjects-100559281","NCT06562088","A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects","A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects","Inclusion Criteria:\n\n1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.\n2. Age range of 18-45 years old (including range), no limit to gender.\n3. Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg\u002Fm2 (including cut-off values).\n\nExclusion Criteria:\n\n1. Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng\u002FL during the screening period.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n3. History of acute cholecystitis within 3 month prior to initiation of screening period.\n4. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.\n5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.\n6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .\n7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.\n8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.\n9. Presence of clinically significant ECG results judged by the investigator at screening.",{"count":140,"type":22},40,[25],"The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.",[28],[80,81],"2024-08-16",{"date":147,"type":33},"2024-08-20",{"date":145,"type":22},{"date":150,"type":22},"2024-12-30",{"name":39,"class":40}]