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

Part of paid clinical trials in Rialto, California.

Sponsor
AstraZeneca
Study ID
NCT07343960
Phase
PHASE1
Status
Recruiting
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Conditions

  • Moderate Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Capivasertib — DRUG
    Capivasertib will be administered orally

Study Details

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).

Key Dates

Start date
Jan 6, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Test: Capivasertib in Moderate hepatic impairment
    Participants with moderate hepatic impairment will receive a single dose of capivasertib.
  • Experimental: Control: Capivasertib in Normal hepatic function
    Participants with normal hepatic function will receive a single dose of capivasertib.

Primary Outcome Measure

Area under concentration time curve from zero to infinity (AUCinf) [ Time Frame: From Day 1 to Day 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteRialtoCalifornia92377-
Research SiteSan AntonioTexas78215-

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Research Site· Rialto, CAResearch Site· San Antonio, TX

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