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

NCT07144111 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GP45942
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Concentration (Cmax) of Inavolisib

  Pre-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 Inavolisib

  Pre-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 Inavolisib

  Pre-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 Inavolisib

  Pre-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 Inavolisib

  Pre-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 Inavolisib

  Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose

Secondary Outcomes (1)

• Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

  From Baseline up to Follow-up (Day 8)

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: Inavolisib

Cohort 2

EXPERIMENTAL

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

Drug: Inavolisib

Cohort 3

EXPERIMENTAL

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

Drug: Inavolisib

Interventions

Inavolisib DRUG

Participants will receive a single oral dose of inavolisib

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

The Texas Liver Institute, Inc.

San Antonio, Texas, 78215, United States

RECRUITING

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Interventions

inavolisib

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GP45942 https://forpatients.roche.com

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)