A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2026-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1

Group Type EXPERIMENTAL

Inavolisib

Intervention Type DRUG

Participants will receive a single oral dose of inavolisib

Cohort 2

Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1

Group Type EXPERIMENTAL

Inavolisib

Intervention Type DRUG

Participants will receive a single oral dose of inavolisib

Cohort 3

Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1

Group Type EXPERIMENTAL

Inavolisib

Intervention Type DRUG

Participants will receive a single oral dose of inavolisib

Interventions

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Inavolisib

Participants will receive a single oral dose of inavolisib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes