Liver function may change how inavolisib works
NCT ID NCT07144111
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 8 times
Summary
This early-phase study looks at how a single dose of the drug inavolisib behaves in people with moderate or severe liver impairment compared to healthy volunteers. Researchers will measure drug levels in the blood and check for side effects. The goal is to understand if liver problems change how the drug is processed, which could guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inavolisib
- What this could lead to
- If successful, this study could help doctors understand how to dose inavolisib safely for patients with liver problems.
- What could go wrong
- This is a very early, small study (32 people) focused on drug levels, not on treating a disease. Results may not apply to real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Orange County Research Center
RECRUITINGLake Forest, California, 92630, United States
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Orlando Clinical Research Center
RECRUITINGOrlando, Florida, 32809, United States
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Pinnacle Clinical Research - San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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The Texas Liver Institute, Inc.
RECRUITINGSan Antonio, Texas, 78215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Liver trouble changes how drugs work: scientists test soticlestat
- Can two experimental drugs be used safely in people with cirrhosis?
- Can a damaged liver change how a new drug works?
- Liver health and drug processing: a closer look at casdatifan
- Liver function may change how belapectin works in the body
- Liver function may change how ammoxetine works