Actively Recruiting
Phase 1 Study to Assess the Impact of Moderate or Severe Liver Impairment on Inavolisib Levels After a Single Oral Dose
Led by Genentech, Inc. · Updated on 2026-08-05
32
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how moderate or severe liver impairment affects the levels of inavolisib, a drug given as a single oral dose, in the body. The study focuses on participants with different degrees of hepatic impairment compared to healthy individuals with normal liver function. This phase 1 open-label study aims to understand the drugs pharmacokinetics, safety, and tolerability in these groups. Participants are divided into three groups based on their liver function healthy participants with normal hepatic function, those with moderate hepatic impairment, and those with severe hepatic impairment. Each participant receives one single oral dose of inavolisib on Day 1. The study uses a parallel design where each group is studied separately but concurrently. During the study, participants will have blood samples taken at multiple time points up to 96 hours after dosing to measure drug concentrations and pharmacokinetic parameters such as maximum concentration and area under the curve. Safety is monitored through reported adverse events up to Day 8. The total participation duration includes dosing and follow-up assessments to evaluate the drugs behavior and safety in participants with varying liver function.
CONDITIONS
Brief 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 between 18.0 and 40.0 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 normal liver function and no history of significant liver disease
- Participants with hepatic impairment must have moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15) liver impairment with stable cirrhosis
- Negative hepatitis C viral load for all participants with hepatic impairment
You will not qualify if you...
- History of Type 1 diabetes or insulin-dependent Type 2 diabetes requiring two or more systemic treatments
- Significant history or symptoms of metabolic, allergic, skin, kidney, blood, lung, heart, digestive, nervous system, or mental health disorders
- Recent serious illness, surgery, or hospitalization within 2 weeks before dosing
- History of gastrointestinal surgery
- Conditions interfering with drug absorption like malabsorption syndrome
- History of active or latent tuberculosis or positive TB test
- Significant allergies or intolerance to drugs, food, or substances
- Use of drugs of abuse including opioids
- Healthy participants excluded if history of alcoholism or drug addiction
- Participants with liver impairment excluded if liver problems are due to cancer or bile duct cancer
- Presence of surgical or artificial portosystemic shunts
- Evidence of hepatorenal syndrome
- Ascites requiring fluid removal
- Progressive liver disease in the past month
- Previous liver transplant
- Hepatic encephalopathy Grade 2 or higher
Research Team
R
Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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