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
AstraZeneca
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).
Description
This is a single dose, non-randomized, open-label, parallel group study. A Screening Period (Day -21 to -2): Participants in moderate impairment group will have an additional assessment of hepatic function stability on Day -7. Treatment and Residential Period: Participants will be resident at the Investigative Site from Day -1 to Day 4 and will receive a single oral dose of capivasertib on Day 1. Follow-up Period: Participants will return for a follow-up visit on Days 9 to 11.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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. * Suppor…
Interventions
- DrugCapivasertib
Capivasertib will be administered orally
Locations (2)
- Research SiteRialto, California
- Research SiteSan Antonio, Texas