Phase I Study on Safety and Pharmacokinetics of Oral Capivasertib in Adults With Moderate Liver Impairment Compared to Normal Liver Function

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, and tolerability of capivasertib in adults with moderate hepatic impairment compared to those with normal liver function. This phase I study aims to understand how the drug behaves in the body and its safety profile in these two groups. Participants will receive a single oral dose of capivasertib while staying at the investigative site from the day before dosing until four days after. The study includes two parallel groups one with moderate hepatic impairment and one with normal liver function. Before dosing, a screening period of up to three weeks includes liver function assessments, with an additional stability check for those with impaired hepatic function. During the study, participants will have blood samples taken to measure drug levels and monitor safety from Day 1 through Day 4, followed by a follow-up visit between Days 9 and 11. Researchers will assess drug concentration over time, maximum levels in the blood, and any adverse events to evaluate how the drug is processed and tolerated. Total participation lasts from screening through follow-up, approximately up to four weeks.

A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment