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Liver function may change how inavolisib works

NCT ID NCT07144111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Orange County Research Center

    RECRUITING

    Lake Forest, California, 92630, United States

  • Orlando Clinical Research Center

    RECRUITING

    Orlando, Florida, 32809, United States

  • Pinnacle Clinical Research - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Texas Liver Institute, Inc.

    RECRUITING

    San Antonio, Texas, 78215, United States

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