RecruitingPhase 1NCT07144111

A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib


Sponsor

Genentech, Inc.

Enrollment

32 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inavolisib for people with hepatic impairment. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 80 Years.

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

DRUGInavolisib

Participants will receive a single oral dose of inavolisib


Locations(4)

Orange County Research Center

Lake Forest, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

The Texas Liver Institute, Inc.

San Antonio, Texas, United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07144111


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