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A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Sponsor: Genentech, Inc.
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
Conditions
Interventions
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