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RECRUITING
NCT07144111
PHASE1

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

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-08-21

Completion Date

2026-09-09

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

DRUG

Inavolisib

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