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A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
RecruitingPhase 1Healthy volunteers welcome
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib
Who can join
Ages 18 to 80 · All sexes · Healthy volunteers welcome
Full eligibility 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 antibody test followed by a negative HCV RNA test * Normal hepatic function and no history of clinically significant hepatic dysfunction Participants with Hepatic Impairment (Cohorts 2 and 3): * Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment * Chronic, stable hepatic insufficiency with features of cirrhosis * Negative hepatitis C viral load Exclusion Criteria: All participants: * History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents * Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder * Significant illness, surgery, or hospitalization within 2 weeks prior to dosing. * History of gastro-intestinal surgery * Malabsorption syndrome or any other condition that would interfere with enteral absorption. * History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * Use of drugs of abuse (including opioids) Healthy participants (Cohort 1): \- History of alcoholism or drug addiction Participants with Hepatic Impairment (Cohorts 2 and 3): * Hepatic impairment due to hepatocellular carcinoma or bile duct cancer * Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt) * Evidence of hepatorenal syndrome * Ascites requiring paracentesis * Any evidence of progressive liver disease in the last 1 month * Receipt of a liver transplant * Hepatic encephalopathy Grade 2 or above
About the study
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.
What is being tested
- Inavolisib (drug)
Sponsor: Genentech, Inc. · Participants: 32 · Started: Aug 21, 2025
Contact the study team
- Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below. · Phone: 888-662-6728 (U.S. and Canada)
Official record on ClinicalTrials.gov — NCT07144111
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.