A Study of Inavolisib in People with Liver Problems
This study is looking at how the drug inavolisib is processed by the body in people with moderate or severe liver problems (hepatic impairment), compared to healthy individuals. Researchers want to understand how liver function affects the levels of inavolisib in the body over time. You might be able to join if you are between 18 and 80 years old, have a body mass index (BMI) between 18 and 40, and weigh at least 45 kg. You'll also need to test negative for hepatitis B surface antigen and HIV. The study measures how much inavolisib is in your blood at different times after taking a single dose. The current recruitment status is unclear, and the study plans to enroll 32 participants.
- Study design
- This is an open-label study, meaning you and the researchers will know which treatment you receive. It will involve about 32 participants.
- What's involved
- You would receive a single oral dose of inavolisib. Blood samples will be taken at various times over 96 hours (4 days) after you take the dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood levels of inavolisib will be measured for up to 96 hours (4 days) after you take the dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07144111
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Recruiting
PHASE1Ages 18–80InterventionalTreatmentGenentech, Inc.
~32 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Inavolisib
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Observed Concentration (Cmax) of Inavolisib
Measured over Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
+5 more outcomes measured
Conditions
Where it's being run
4 sites across 3 statesTexas2
California1
Florida1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Who to contact
Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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
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)
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
What this trial measures
- Maximum Observed Concentration (Cmax) of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
- Area Under Curve (AUC) from Hour 0 to the Last Measurable Concentration (AUC [0-t]) of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
- AUC from Zero to Infinity (AUC [0-inf]) Extrapolated of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
- Geometric Mean Ratio of Cmax of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
- Geometric Mean Ratio of AUC (0-t) of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
- Geometric Mean Ratio of AUC (0-inf) of InavolisibPre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose