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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Moderate Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Capivasertib	Capivasertib will be administered orally

Timeline

• Start date: 2026-01-06
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2026-01-15
• Last updated: 2026-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study