NCT07144111 · Genentech, Inc.
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
What this study is about
This where both patients and doctors know the treatment given study will evaluate the effect on the how the drug moves through the body (PK), safety, and tolerability of a single taken by mouth dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Lake Forest, California
- Orlando, Florida
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations