A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants Wi… (NCT07343960) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
United States20 participantsStarted 2026-01-06
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* Body weight of at least 50 kg and Body Mass Index (BMI) of between ≥ 18 up to ≤ 40 kg/m2.
* Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants must have suitable veins for cannulation or repeated venipuncture.
* Non-smoker, defined as a participant who has not smoked previously or who has discontinued smoking or the use of other nicotine/nicotine-containing products at least 3 months before the Screening Visit.
* 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.
* 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/transaminase (AST) for moderate hepatic impairment.
* Stable hepatic impairment
* For participants with normal hepatic function, Bilirubin \< 1.5 Ă— ULN, alanine aminotransferase (ALT), AST, albumin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) \< 1.2 Ă— ULN. Creatinine \< ULN. White blood cell count \> lower limit of normal (LLN).
Key Exclusion Criteria:
* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, si…
What they're measuring
1
Area under concentration time curve from zero to infinity (AUCinf)
Timeframe: From Day 1 to Day 4
2
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)