Actively Recruiting
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib
Led by Genentech, Inc. · Updated on 2026-06-08
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 way the body processes the drug inavolisib. This open-label Phase 1 study will compare participants with moderate or severe hepatic impairment to healthy participants with normal liver function to assess the drug's pharmacokinetics, safety, and tolerability. The study is sponsored by Genentech, Inc. and aims to better understand inavolisib's behavior in different liver conditions. Participants will receive a single oral dose of inavolisib on Day 1. The study includes three groups: healthy participants with normal liver function, participants with moderate hepatic impairment, and participants with severe hepatic impairment. Each participant will take one dose of the drug, and no placebo or randomization is involved as all receive the active drug. During the study, researchers will collect blood samples at multiple timepoints up to 96 hours post-dose to measure the drug concentration and calculate pharmacokinetic parameters such as maximum concentration and area under the curve. Safety will be monitored through adverse event reporting up to Day 8. The entire participation involves screening, single dose administration, pharmacokinetic sampling, and follow-up for safety assessment.
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...
- Adults aged 18 to 80 years
- Body Mass Index between 18.0 and 40.0 kg/m2 and body weight at least 45 kg
- Negative hepatitis B surface antigen test
- Positive or negative hepatitis B surface antibody 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 refrain from 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 to 9) or severe (Child-Pugh score 10 to 15) stable liver impairment with cirrhosis and negative hepatitis C viral load
You will not qualify if you...
- History of insulin-dependent Type 1 or Type 2 diabetes or diabetes requiring two or more systemic treatments
- Significant metabolic, allergic, skin, kidney, blood, lung, heart, gastrointestinal, neurological, or psychiatric disorders
- Significant illness, surgery, or hospitalization within 2 weeks before dosing
- History of gastrointestinal surgery
- Malabsorption syndrome or conditions affecting drug absorption
- History of active or latent tuberculosis or positive TB test
- Significant hypersensitivity or allergy to drugs, food, or substances
- Use of drugs of abuse including opioids
- Healthy participants with history of alcoholism or drug addiction
- Participants with hepatic impairment due to liver cancer or bile duct cancer
- Having surgical or artificial portosystemic shunt
- Evidence of hepatorenal syndrome
- Ascites requiring paracentesis
- Progressive liver disease in the last month
- Receipt of liver transplant
- Hepatic encephalopathy Grade 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive a single oral dose of inavolisib on Day 1.
Multiple visits for pharmacokinetic blood sampling up to 96 hours post-dose
Duration - Up to 7 days after treatment
Participants are monitored for adverse events and safety up to Day 8 after dosing.
1 follow-up visit
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
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
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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