[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacokinetic-analysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacokinetic-analysis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100639984","plasma-kinetics-of-levobupivacaine-after-transversus-abdominis-plane-tap-block-in-abdominal-surgery-100639984",false,"NCT07581275","Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery","Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery: A Prospective Study and Definition of a Safety Window for Intravenous Lidocaine Administration","LEVO-TAP-PK","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled elective abdominal surgery under general anesthesia\n* Planned ultrasound-guided TAP block as part of standard perioperative analgesic care\n* Able to understand and speak French sufficiently to understand the study information and consent form\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent\n* Known allergy or hypersensitivity to amide local anesthetics\n* Severe hepatic impairment\n* Renal impairment (estimated glomerular filtration rate \\\u003C50 mL\u002Fmin\u002F1.73 m²)\n* Contraindication to repeated blood sampling or inability to complete the sampling schedule\n* Participation in another clinical study that could affect absorption, distribution, metabolism, or elimination of local anesthetics\n* Pregnancy\n* Emergency surgery or life-threatening urgent condition\n* Immediate postoperative instability requiring intensive care transfer (e.g., hemodynamic instability)\n* Inability to understand French sufficiently for study information and consent\n* Persons requiring special legal protection for consent (e.g., minors, guardianship, incapacity to consent)","ALL","18 Years","75 Years",{"count":21,"type":22},26,"ESTIMATED","OBSERVATIONAL","This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS\u002FMS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.",[26,27,28,29,30],"Abdominal Surgery Patients","Transversus Abdominis Plane (TAP) Block","Pharmacokinetic Analysis","Levobupivacaine","Local Anaesthetic Systemic Toxicity","NOT_YET_RECRUITING","2026-05-06",{"date":34,"type":35},"2026-05-12","ACTUAL",{"date":37,"type":22},"2026-07-01",{"date":39,"type":22},"2026-12-15",{"name":41,"class":42},"University of Liege","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100627194","phase-1-an-open-label-pharmacokinetic-study-of-asp-001-formulations-in-healthy-volunteers-100627194","NCT07445464","An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers","A Phase 1, Randomized, Open-Label, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of Asp-001, 2 Mg And 5 Mg Orally Disintegrating Tablets (Formulations A And B) With Sibelium® 5 Mg Tablet in Healthy Participants","Inclusion Criteria:\n\n1. Male or female, ≥18 and ≤65 years of age at screening, with body mass index (BMI) ≥18.5 and ≤32.0 kg\u002Fm2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.\n2. Healthy as defined by:\n\n   1. the absence of clinically significant illness and surgery (including abdominal or gastrointestinal surgery that may alter drug absorption) within 4 weeks prior to dosing.\n   2. the absence of clinically significant history of neurological (including Parkinson's disease or other extrapyramidal disorders), endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric (including depression), gastrointestinal, renal, hepatic, and metabolic disease.\n3. Non smoker, defined as no use of tobacco or nicotine containing products (including cigarettes, e cigarettes, cigars, pipes, or smokeless tobacco) for at least 6 months prior to screening.\n4. Female participants of non-childbearing potential must be:\n\n   1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle stimulating hormone (FSH) levels ≥40 mIU\u002FmL; or\n   2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or having had a tubal ligation performed at least 3 months prior to dosing.\n5. Sexually active female participants of childbearing potential and non-sterile male participants must be willing to use an acceptable contraceptive method throughout the study as detailed in section 7.1.\n6. Willing to take off dentures or mouth piercing at the time of dosing.\n7. Able to understand the study procedures and provide signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Any clinically significant abnormal finding at physical examination at screening.\n2. PHQ-9 score \\> 10 at screening or baseline (Day -1).\n3. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening. Any abnormalities or deviations outside the normal ranges for any clinical laboratory testing can be repeated once at the discretion of the investigator and\u002For designee.\n4. Any of the following laboratory parameters above 1.5× upper limit of normal (ULN) at screening or baseline (Day -1): AST, ALT, direct bilirubin, indirect bilirubin, and total bilirubin. Values over 1.5× ULN may be repeated once for confirmation if the investigator considers it reasonable (e.g., potential elevation due to recent strenuous physical activity).\n5. History of clinically significant liver disease, impaired synthetic liver function, or jaundice. Resolved childhood jaundice is not exclusionary.\n6. Value of creatinine clearance (CrCl) \\\u003C60 mL\u002Fmin, as estimated by the Cockcroft-Gault equation.\n7. Positive pregnancy test or lactating female participant.\n8. Positive urine drug screen, urine cotinine test, or alcohol breath test.\n9. Known allergic reactions to flunarizine or other related drugs, or to any excipient in the formulation.\n10. Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening. Any abnormalities or deviations outside the normal range for vital signs and ECG can be repeated at the discretion of the investigator and\u002For designee.\n11. History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month, or use of cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives (including heroin) or amphetamine derivatives within 3 months prior to screening.\n12. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 standard drinks for females or 21 standard drinks for males of alcohol per week (1 standard drink = 375 mL of mid-strength beer 3.5% alcohol\u002Fvolume, 100 mL of wine 13.5% alcohol\u002Fvolume, or 30 mL of distilled alcohol 40% alcohol\u002Fvolume).\n13. Use of medications within the the following timeframes prior to dosing:\n\n    * Depot injections or drug implants: within 3 months.\n    * Strong CYP2D6 inhibitors or strong CYP inducers such as fluoxetine, paroxetine, bupropion, quinidine, cinacalcet, terbinafine, mirabegron, darifenacin, rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's wort: within 30 days.\n    * Prescription medications: within 14 days.\n    * Vaccines (including COVID 19 vaccines): within 14 days.\n    * Over the counter (OTC) medications and natural health products (herbal, homeopathic, probiotics, vitamins, minerals, amino acids, essential fatty acids, protein supplements): within 7 days, except occasional paracetamol up to 2 g\u002Fday.\n\n    No concomitant medications are permitted during the study except those required for AE management or those specifically exempted by the Investigator and\u002For designee as unlikely to affect PK or safety.\n14. Concomitant participation in an interventional or observational trial, or administration of an investigational device or non-biological drug within 30 days (or 5 half-lives, whichever is longer) prior to dosing, or administration of an investigational biological drug within 90 days (or 5 half-lives, whichever is longer) prior to dosing.\n15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.\n16. Hemoglobin \\\u003C125 g\u002FL for males and \\\u003C110 g\u002FL for females. One repeat test is permitted at the discretion of the Investigator and\u002For designee.\n17. Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that in the opinion of the investigator and\u002For designee would be likely to interfere with successful completion of the dosing procedure.\n18. Any reason which, in the opinion of the Investigator and\u002For designee, would prevent the participant from participating in the study.",true,"65 Years",{"count":53,"type":22},12,"INTERVENTIONAL",[56],"PHASE1","This study will assess the pharmacokinetics (PKs), safety and tolerability of ASP-001 in healthy volunteers. ASP-001 is an orally disintegrating tablet (ODT) formulation of flunarizine. This study will assess two formulations, Formulation A and Formulation B, at dose levels of 2 and 5 mg compared to the reference product, the Sibelium brand of flunarizine 5 mg tablet.\n\nWhilst this is not a first-in-human (FIH) study of flunarizine, which is available in countries outside of Australia and has been studied extensively, it is a FIH study of ASP-001. In this open-label study, 12 participants will be assigned to one of five dosing sequences, in which they will receive a single dose of ASP-001 or Sibelium 5 mg in five separate dosing periods. The study drugs will be:\n\n* Treatment A: ASP-001 Formulation A, 5 mg\n* Treatment B: ASP-001 Formulation A, 2 mg\n* Treatment C: ASP-001 Formulation B, 5 mg\n* Treatment D: ASP-001 Formulation B, 2 mg\n* Treatment E: Sibelium, 5 mg Each dosing period will be separated by at least a 7-day washout period after the day of dosing. Approximately 14 days after the fifth and final dosing day, participants will return to the site to complete their end of study assessments.\n\nAboriginal and Torres Strait Islander participants will not be targeted directly; however, they will be permitted to be on-study if they meet all of the eligibility criteria. Participants under the age of 18 will not be permitted on study.",[28],"2026-02-25",{"date":61,"type":35},"2026-03-03",{"date":63,"type":22},"2026-04-09",{"date":65,"type":22},"2026-07",{"name":67,"class":68},"Aspartes Pharmaceuticals, Inc.","INDUSTRY"]