Menu
Recruiting NCT07144111

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

Phase I Interventional Hepatic Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inavolisib.
Who it may be relevant to
Registry conditions: Hepatic Impairment. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Inavolisib
    Participants will receive a single oral dose of inavolisib

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: From Baseline up to Follow-up (Day 8)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Orange County Research Center — Lake Forest
  • Orlando Clinical Research Center — Orlando
  • The Texas Liver Institute, Inc. — San Antonio
  • Pinnacle Clinical Research - San Antonio — San Antonio

Identifiers

NCT: NCT07144111 · GP45942

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗