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
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
- DrugInavolisib
Participants will receive a single oral dose of inavolisib
Locations (4)
- Orange County Research CenterLake Forest, California
- Orlando Clinical Research CenterOrlando, Florida
- The Texas Liver Institute, Inc.San Antonio, Texas
- Pinnacle Clinical Research - San AntonioSan Antonio, Texas