[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacokinetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacokinetic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614630","phase-1-pharmacokinetics-of-olverembatinib-in-participants-with-hepatic-impairment-100614630",false,"NCT07282093","Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment","An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib","Inclusion Criteria:\n\n1. The participant voluntarily joins the study, signs the Informed Consent Form, and demonstrates good compliance.\n2. Body Mass Index (BMI) between 18 and 30 kg\u002Fm² (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.\n3. The investigator judges the participant suitable to participate in this study based on physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG) examination.\n4. Female participants of childbearing potential must agree to use effective contraception during the study and for 3 months after the study ends; must have a negative serum pregnancy test within 7 days prior to study enrollment; and must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 3 months after the study ends.\n5. Additional Criteria for Participants with hepatic impairment Only:\n\n1\\. Chronic hepatic impairment due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes.\n\n2\\. Hepatic impairment classified as Child-Pugh Class A, B, or C. 3. Coagulation function: INR ≤ 2.5 without intervention with procoagulant drugs (after a 2-week washout period). Hematology: Neutrophils ≥ 1.0 × 10⁹\u002FL, Hemoglobin ≥ 70 g\u002FL, Platelets ≥ 30 × 10⁹\u002FL. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 times the Upper Limit of Normal (ULN); Total Bilirubin ≤ 5 × ULN.\n\n4\\. Stable treatment for hepatic impairment, complications, and other concomitant diseases prior to study drug administration, with no need for dosage adjustment. Treatment for hepatic impairment must have been stable for at least 4 weeks.\n\nExclusion Criteria:\n\n1. Drug-induced liver injury.\n2. Any of the following conditions: history of liver transplantation; presence of acute or worsening liver injury due to any cause; liver failure; concurrent Grade 3\u002F4 hepatic encephalopathy; active hepatocellular carcinoma lesions; severe esophageal or gastric varices or history of rupture and bleeding; severe\u002Flate-stage ascites or pleural effusion requiring paracentesis\u002Fthoracentesis and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.\n3. History of cholestasis, biliary tract infection, or other diseases affecting bile excretion within 3 months prior to screening.\n4. Esophageal or gastric variceal bleeding due to portal hypertension within 3 months prior to screening, or history of portosystemic shunt surgery (including Transjugular Intrahepatic Portosystemic Shunt - TIPS) within 6 months prior to screening.\n5. History of significant allergy or intolerance to any drug, food, or other substance.\n6. History of any clinically significant disease in the neurological, cardiovascular, digestive, respiratory, urinary, endocrine, hematological, immune systems, or any other disease or condition that the investigator believes may affect the trial results.\n7. History of surgery that may affect drug absorption, distribution, metabolism, or excretion, or plans for surgery or other reasons requiring hospitalization during the expected study period.\n8. Uncontrolled bacterial, viral, parasitic, or fungal infection requiring treatment at the time of screening (except Hepatitis B), or history of severe active infection within 1 month prior to screening.\n9. Positive Human Immunodeficiency Virus (HIV) antigen\u002Fantibody test at screening. For participants with normal hepatic function: Positive Treponema pallidum antibody. For hepatically impaired participants: Active syphilis.\n10. Use of systemic medications with known potential hepatotoxicity for 7 consecutive days or more within 14 days prior to study drug administration.\n11. Use of traditional Chinese medicine (herbal medicines, proprietary Chinese medicines), dietary supplements, or vitamins within 14 days prior to study drug administration.\n12. Systemic use of moderate or potent CYP3A4 inhibitors (e.g., itraconazole, fluconazole) or moderate or potent CYP3A4 inducers within 14 days prior to study drug administration.\n13. Positive urine drug screen or alcohol breath test at screening.\n14. Excessive alcohol intake (averaging more than 14 units of alcohol per week) within 3 months prior to screening, or inability to abstain from alcohol during the trial period.\n15. Consumption of grapefruit\u002Fjuice, foods or beverages rich in methylxanthines, engagement in strenuous exercise, or presence of other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to study drug administration, and inability to abstain from these during the hospitalization period.\n16. Participation in other investigational drug or medical device clinical trials within 3 months prior to the first dose of the study drug, or participation in 3 or more drug or medical device clinical trials within the past year. If the half-life of the other investigational drug is long, a longer interval is required, at least 5 times the half-life of that drug.\n17. Blood donation (or blood loss) ≥ 400 mL, or receipt of blood transfusion or blood products within 3 months prior to screening.\n18. History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.\n19. Unwillingness or inability to comply with the study procedures outlined in the protocol, or any other reason considered by the investigator as unsuitable for participation in this clinical study.\n20. Additional Criteria for Participants with Normal Hepatic Function Only:\n\n1). For participants with normal hepatic function: History of hepatitis, Hepatitis B, or Hepatitis C. History of hepatic impairment, or findings during screening physical examination or laboratory tests suggesting existing or potential hepatic impairment; Positive Hepatitis B Surface Antigen (HBsAg) or positive anti-HCV antibody.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.",[28,29],"Pharmacokinetic","Olverembatinib",[31],"olverembatinib","RECRUITING","2025-12-21",{"date":35,"type":36},"2025-12-23","ACTUAL",{"date":38,"type":36},"2025-11-11",{"date":40,"type":22},"2026-10-31",{"name":42,"class":43},"Ascentage Pharma Group Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100467457","therapeutic-monitoring-of-antibiotics-in-intensive-care-patients-a-cohort-study-poptdm-icu-100467457","NCT05367011","Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU","Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation","Inclusion Criteria:\n\n* Patient ≥ 18 year-old.\n* Patient hospitalized in intensive care,\n* Patient receiving an antibiotic for sepsis or septic shock\n* Patient or family member who does not object to participating in the study\n\nExclusion Criteria:\n\nPatient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.\n\n* Patient receiving antibiotic treatment for antibiotic prophylaxis.\n* Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.\n* Pregnant and \u002F or lactating women.",{"count":53,"type":22},2500,"OBSERVATIONAL","Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.\n\nThe main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).\n\nThis study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.",[57,58,28],"Intensive Care Unit","Antibiotic Therapy",[60,61,62],"Antibiotic","Intensive care","Therapeutic drug monitoring","NOT_YET_RECRUITING","2022-08-03",{"date":66,"type":36},"2022-08-04",{"date":68,"type":22},"2022-09-01",{"date":70,"type":22},"2028-09-01",{"name":72,"class":73},"Poitiers University Hospital","OTHER"]