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

Recruiting now · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT07144111

Run by

Genentech, Inc.

People needed

32

Starts

2025-08-21

Expected to finish

2026-09-06

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orange County Research Center — Lake Forest, California, United States (enrolling)
• Orlando Clinical Research Center — Orlando, Florida, United States (enrolling)
• The Texas Liver Institute, Inc. — San Antonio, Texas, United States (enrolling)
• Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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