NCT07144111PHASE1RecruitingAccepts Healthy Volunteers
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Genentech, Inc.
Start Date
8/21/2025
Completion Date
9/6/2026
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 Criteria
Age Range: 18 years to 80 years
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
Interventions
DRUG
Inavolisib
Conditions
Hepatic Impairment
Locations
Orange County Research Center
Lake Forest, California 92630
United States
Orlando Clinical Research Center
Orlando, Florida 32809
United States
The Texas Liver Institute, Inc.
San Antonio, Texas 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
United States