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

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.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: All participants: * Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m\^2), inclusive, and body weight \>=45 kg. * Negative hepatitis B surface antigen (HBsAg) test * Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb * Negative HIV (Human Immunodeficiency Virus) test * Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile * Males will agree to use contraception and will refrain from sperm donation Healthy participants (Cohort 1): * Negative hepatitis C virus (HCV) antibody test or positive HCV…

Interventions

Drug
Inavolisib
Participants will receive a single oral dose of inavolisib

Locations (4)

Orange County Research Center
Lake Forest, California
Orlando Clinical Research Center
Orlando, Florida
The Texas Liver Institute, Inc.
San Antonio, Texas
Pinnacle Clinical Research - San Antonio
San Antonio, Texas

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

Summary

Eligibility

Interventions

Locations (4)

Compensation

Run this study?

Details

Conditions