RecruitingPhase 1NCT07343960

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


Sponsor

AstraZeneca

Enrollment

20 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a cancer drug called capivasertib behaves in the body of people with moderate liver problems. When the liver isn't working normally, it can affect how drugs are processed — this study helps researchers understand if dose adjustments are needed for patients with liver disease. **You may be eligible if...** - You have moderate liver impairment (classified as Child-Pugh Class B) - You weigh at least 50 kg and have a BMI between 18 and 40 - You are a non-smoker (stopped at least 3 months ago) - You have stable liver disease (not rapidly worsening) **You may NOT be eligible if...** - You have severe or uncontrolled medical conditions (uncontrolled high blood pressure, active bleeding disorders, kidney transplant) - You have moderate or severe kidney problems - You have HIV, active hepatitis B, or hepatitis C - You have rapidly deteriorating liver function, liver cancer, or severe complications like major bleeding from the esophagus - You have had a liver transplant or severe liver encephalopathy (brain confusion due to liver failure) - Your blood sugar levels are poorly controlled (HbA1c of 8% or higher) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapivasertib

Capivasertib will be administered orally


Locations(2)

Research Site

Rialto, California, United States

Research Site

San Antonio, Texas, United States

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NCT07343960


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