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Clinical Trials/ISRCTN46432183
ISRCTN46432183Active, not recruitingPhase 1

A phase I, open-Label, single-Dose study to evaluate the effect of mild or moderate hepatic impairment on the pharmacokinetics of fenebrutinib

Genentech Inc.0 sites32 target enrollmentStarted: October 10, 2023Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
32
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Male and female participants between 18 to 75 years of age, inclusive, at screening
  • •2. Body weight =45 kilograms (kg) and within body mass index (BMI) range 18.0 to 42.0 kilograms per square meter (kg/m2), inclusive
  • •Additional inclusion criteria for participants with normal hepatic function (Cohort 1) only:
  • •1. In reasonably good health for their age
  • •2. Matched to participants with mild or moderate hepatic impairment in sex, age
  • •(±10 years), and body weight (±15%)
  • •3. Negative hepatitis panel
  • •4. Normal hepatic function and no history of clinically significant hepatic dysfunction
  • •5. Estimated glomerular filtration rate =80 millilitre per minute (mL/min) at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation.
  • •Additional inclusion criteria for participants with hepatic impairment (Cohorts 2 and 3) only:
  • •1. Chronic (>6 months), stable (no acute episodes of illness within the previous 1 month prior to Screening due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period.
  • •2. Considered to have mild or moderate hepatic impairment and has been clinically stable for at least 1 month prior to Screening. To be classified as having hepatic impairment, participants must have a Child-Pugh score of 5 to 6 (inclusive; mild) or 7 to 9 (inclusive; moderate) with known medical history of liver disease and unambiguous medical history.
  • •3. Negative hepatitis B virus core antibody and HbsAg screens and negative hepatitis C viral load.
  • •4. Estimated glomerular filtration rate =60 mL/min at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation.
  • •Other protocol defined inclusion criteria could apply.

Exclusion Criteria

  • •1. Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the dose of study drug.
  • •2. History of surgical or artificial shunts (i.e., transjugular intrahepatic portosystemic procedure).
  • •3. History of malignancy within 5 years prior to screening, except for completely excised basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ.
  • •4. Significant illness, including infections, surgery, or hospitalization within the 2 weeks prior to dosing.
  • •5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that uncomplicated hernia repair, appendectomy, and/or cholecystectomy will be allowed.
  • •6. Malabsorption syndrome or other condition that would interfere with enteral absorption.
  • •Additional exclusion criteria for participants with hepatic impairment (Cohorts 2 and 3) only:
  • •1. Evidence of progressive liver disease that has worsened or is worsening within 1 month prior to Screening.
  • •2. Evidence of hepatorenal syndrome
  • •3. Ascites requiring paracentesis within 3 months prior to Check-in (Day -1) or other intervention, with the exception of diuretics.
  • •4. Required treatment for gastrointestinal bleeding within 12 months prior to Check-in (Day -1)
  • •5. Receipt of a liver transplant
  • •6. Required additional medication for hepatic encephalopathy within 12 months prior to check-in (Day -1), unless deemed acceptable by the investigator.
  • •7. One or more of the following laboratory results:
  • •Alkaline phosphatase >10 × upper limit of normal (ULN).
  • •Alanine aminotransferase or aspartate aminotransferase >5 × ULN.
  • •Bilirubin >3 × ULN in the absence of Gilbert’s Syndrome or hemolysis.
  • •Other protocol defined exclusion criteria could apply.

Investigators

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