Recruiting
Phase 1

Inavolisib

Sponsor:

Genentech, Inc.

Code:

NCT07144111

Conditions

Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Inavolisib

Study Details

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

Study ID

NCT07144111

Start date

Aug 21, 2025

Status verified date

Sep, 2026

Completion date

Nov 16, 2026

Anticipated

Primary completion date

Nov 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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

experimental: Cohort 2

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

experimental: Cohort 3

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

Interventions

Inavolisib

Participants will receive a single oral dose of inavolisib

Primary outcome measure

  • Maximum Observed Concentration (Cmax) of Inavolisib [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

The Texas Liver Institute, Inc.

Recruiting

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.