RecruitingPhase 1NCT07144111

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

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

Sponsor

Genentech, Inc.

Enrollment

32 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatic Impairment

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria14

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 Criteria19

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