Actively Recruiting
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Led by Genentech, Inc. · Updated on 2026-05-11
32
Participants Needed
4
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m²) and body weight at least 45 kg
- Negative hepatitis B surface antigen (HBsAg) test
- Positive or negative hepatitis B surface antibody (HBsAb) test
- Negative HIV test
- Females must not be pregnant or breastfeeding and must be postmenopausal or surgically sterile
- Males must agree to use contraception and avoid sperm donation
- Healthy participants must have a negative hepatitis C virus (HCV) antibody test or positive HCV antibody test with negative HCV RNA test
- Healthy participants must have normal liver function with no history of significant liver problems
- Participants with hepatic impairment must have moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score 10 to 15) liver impairment
- Participants with hepatic impairment must have chronic, stable liver insufficiency with cirrhosis features
- Participants with hepatic impairment must have a negative hepatitis C viral load
You will not qualify if you...
- History of Type 1 diabetes or insulin-dependent Type 2 diabetes or requiring two or more systemic treatments
- Significant history or symptoms of metabolic, allergic, skin, kidney, blood, lung, heart, stomach, nerve, or psychiatric disorders
- Recent serious illness, surgery, or hospitalization within 2 weeks before dosing
- History of gastrointestinal surgery
- Malabsorption syndrome or conditions interfering with drug absorption
- History of active or latent tuberculosis or positive QuantiFERON�AE TB Gold test
- History of serious allergies or intolerance to drugs, food, or other substances
- Use of drugs of abuse, including opioids
- Healthy participants with history of alcoholism or drug addiction
- Participants with hepatic impairment caused by liver cancer or bile duct cancer
- Presence of surgical or artificial portosystemic shunt
- Evidence of hepatorenal syndrome
- Ascites needing paracentesis
- Progressive liver disease in the last month
- History of liver transplant
- Hepatic encephalopathy Grade 2 or above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
3
The Texas Liver Institute, Inc.
San Antonio, Texas, United States, 78215
Actively Recruiting
4
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
R
Reference Study ID Number: GP45942 https://forpatients.roche.com
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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