Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2025-08-20; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-09-17
Trial Details
NCT Number NCT07144111
Lead Sponsor Genentech, Inc.
Conditions Hepatic Impairment
Enrollment 32 participants
Start Date 2025-08-21
Primary Completion 2026-09-04 (estimated)
Study Completion 2026-09-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-05