RECRUITING

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

Talk to us

Conditions

Hepatic Impairment

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib

Quick Facts

Study Start:2025-08-21
Study Completion:2026-09-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07144111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m\^2), inclusive, and body weight \>=45 kg.
  2. * Negative hepatitis B surface antigen (HBsAg) test
  3. * Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb
  4. * Negative HIV (Human Immunodeficiency Virus) test
  5. * Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile
  6. * Males will agree to use contraception and will refrain from sperm donation
  7. * Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test
  8. * Normal hepatic function and no history of clinically significant hepatic dysfunction
  9. * Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment
  10. * Chronic, stable hepatic insufficiency with features of cirrhosis
  11. * Negative hepatitis C viral load
  1. * History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents
  2. * Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
  3. * Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.
  4. * History of gastro-intestinal surgery
  5. * Malabsorption syndrome or any other condition that would interfere with enteral absorption.
  6. * History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test
  7. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  8. * Use of drugs of abuse (including opioids)
  9. * Hepatic impairment due to hepatocellular carcinoma or bile duct cancer
  10. * Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt)
  11. * Evidence of hepatorenal syndrome
  12. * Ascites requiring paracentesis
  13. * Any evidence of progressive liver disease in the last 1 month
  14. * Receipt of a liver transplant
  15. * Hepatic encephalopathy Grade 2 or above

Contacts and Locations

Study Contact

Reference Study ID Number: GP45942 https://forpatients.roche.com
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Genentech, Inc.

Study Locations (Sites)

Orange County Research Center
Lake Forest, California, 92630
United States
Orlando Clinical Research Center
Orlando, Florida, 32809
United States
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-21
Study Completion Date2026-09-06

Study Record Updates

Study Start Date2025-08-21
Study Completion Date2026-09-06

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatic Impairment