[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-hepatic-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-hepatic-impairment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100619387","phase-1-a-phase-i-study-to-investigate-the-pharmacokinetics-and-safety-of-capivasertib-in-participants-with-moderate-hepatic-impairment-100619387",false,"NCT07343960","A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment","A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* Body weight of at least 50 kg and Body Mass Index (BMI) of between ≥ 18 up to ≤ 40 kg\u002Fm2.\n* Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Participants must have suitable veins for cannulation or repeated venipuncture.\n* Non-smoker, defined as a participant who has not smoked previously or who has discontinued smoking or the use of other nicotine\u002Fnicotine-containing products at least 3 months before the Screening Visit.\n* Supporting documents confirming the participant's hepatic impairment must be available (a liver biopsy is preferable but not mandatory); participants must be classified by the Investigator as Child Pugh class B.\n* Participants must meet National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG) classification of total bilirubin 1.5 to 3\\*upper limit of normal (ULN) and any Aspartate aminotransferase\u002Ftransaminase (AST) for moderate hepatic impairment.\n* Stable hepatic impairment\n* For participants with normal hepatic function, Bilirubin \\\u003C 1.5 × ULN, alanine aminotransferase (ALT), AST, albumin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) \\\u003C 1.2 × ULN. Creatinine \\\u003C ULN. White blood cell count \\> lower limit of normal (LLN).\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, significant aneurysm, renal transplant and active bleeding diseases) which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib.\n* History of primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.\n* Active tuberculosis infection.\n* Known Human Immunodeficiency Virus (HIV) infection, active hepatitis B or C infection, positive hepatitis C antibody, and\u002For positive hepatitis B virus surface antigen.\n* Clinically significant abnormalities of glucose metabolism as defined by HemoglobinA1c (HbA1c) ≥ 8.0% (63.9 mmol\u002Fmol) at screening.\n* Moderate or severe renal dysfunction according to age-related creatinine clearance estimated using CKD-EPI formula (i.e., creatinine clearance less than 60 mL\u002Fmin).\n* Fluctuating or rapidly deteriorating hepatic function.\n* Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.\n* Severe portal hypertension or surgical porto-systemic shunts.\n* Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and\u002For disease of the liver.\n* Clinically relevant hepatic encephalopathy (Grade 3 or more).\n* Severe ascites.\n* Esophageal variceal bleeding (unless banded) within the past 2 months.\n* Post-liver transplantation.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).",[28],"Moderate Hepatic Impairment",[30,31,32,33,34,35],"Hepatic function","Anti-cancer agent","Pyrrolopyrimidine-derived compound","Liver metabolism","Serine\u002Fthreonine protein kinase AKT","Pharmacokinetics","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2026-01-06",{"date":44,"type":22},"2026-11-11",{"name":46,"class":47},"AstraZeneca","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100590047","phase-1-pharmacokinetics-pk-and-safety-of-zanzalintinib-in-participants-with-moderate-hepatic-impairment-hi-100590047","NCT06962332","Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* All Participants:\n\n  * No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.\n  * A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.\n  * Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.\n* Participants with Moderate HI Only:\n\n  * Adequate bone marrow function, at the screening and dosing visit.\n  * Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \\> 1.5\\* upper limit of normal (ULN) and ≤ 3\\* ULN at the screening and dosing visit.\n  * Has a diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at the screening visit with features of cirrhosis due to any etiology.\n* Healthy Control Participants Only:\n\n  * Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male\u002Ffemale ratio), and smoking status ratio (smokers\u002Fnon-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.\n\nKey Exclusion Criteria:\n\n* All Participants:\n\n  * • History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and\u002For excretion of orally administered drugs.\n  * Has or is at risk for major cardiac events or dysfunction.\n* Participants with Moderate HI Only:\n\n  * History of liver or other solid organ transplant.\n  * Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.\n  * Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.\n  * Clinical evidence of severe ascites at the screening visit or at check in.\n* Healthy Control Participants Only:\n\n  * History or presence of alcohol or drug abuse within the past 2 years prior to dosing.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","75 Years",{"count":21,"type":22},[25],"The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.",[60,28],"Hepatic Impairment",[62,35],"Zanzalintinib","2025-06-17",{"date":65,"type":40},"2025-06-22",{"date":67,"type":40},"2025-05-13",{"date":69,"type":22},"2026-04",{"name":71,"class":47},"Exelixis"]