Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment

Last updated: January 17, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

1

Condition

Nephrotic Syndrome

Primary Biliary Cholangitis

Treatment

IXP

Clinical Study ID

NCT06529796
VX20-147-006
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched healthy participants.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Cohorts 1 and 3: Participants with Hepatic Impairment

  • Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A)

  • Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B)

  • Cohorts 2 and 4: Healthy Participants

  • Participants will be matched during screening to participants with mild (Cohort

  1. or moderate (Cohort 3) hepatic impairment according to each of the followingparameters: age (± 10 years); sex; and BMI (± 15%)

Exclusion

Key Exclusion Criteria:

  • Cohorts 1 and 3: Participants with Hepatic Impairment

  • Acute febrile illness within 14 days and/or acute illness within 5 days beforefirst dose of study drug

  • Participants who smoke

  • Cohorts 2 and 4: Healthy Participants

  • Acute febrile illness within 14 days and/or acute illness within 5 days beforefirst dose of study drug

  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: IXP
Phase: 1
Study Start date:
August 02, 2024
Estimated Completion Date:
December 20, 2024

Study Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Connect with a study center

  • Division of Clinical Pharmacology, University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • GCP Research

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

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