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NCT Number: NCT07144111

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

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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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center, Lake Forest, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inavolisib

Drug

Participants will receive a single oral dose of inavolisib

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: From Baseline up to Follow-up (Day 8)

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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