Status:
RECRUITING
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Lead Sponsor:
Genentech, Inc.
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07144111
Start Date
August 21 2025
End Date
September 6 2026
Last Update
January 9 2026
Active Locations (4)
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1
Orange County Research Center
Lake Forest, California, United States, 92630
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
The Texas Liver Institute, Inc.
San Antonio, Texas, United States, 78215
4
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States, 78229