A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Last updated: July 10, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Healthy Volunteers

Treatment

Repotrectinib

Clinical Study ID

NCT06352528
CA127-1070
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.

i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.

ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.

  • Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.

i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.

ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.

  • Inclusion Criteria for a Matched Healthy Participant (Group 3):.

i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.

ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.

iii) Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.

Exclusion

Exclusion Criteria:

  • Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.

i) Any major surgery within 4 weeks of the study intervention administration.

ii) History of drug abuse within 1 year of study intervention administration.

iii) History of alcohol abuse within 1 year of study intervention administration.

iv) Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Repotrectinib
Phase: 1
Study Start date:
April 29, 2024
Estimated Completion Date:
July 24, 2025

Connect with a study center

  • Local Institution - 0003

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Local Institution - 0006

    Miami Lakes, Florida 33014-2811
    United States

    Site Not Available

  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Local Institution - 0001

    Orlando, Florida 32809
    United States

    Site Not Available

  • Local Institution - 0005

    Orlando, Florida 32809-3017
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Local Institution - 0002

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Local Institution - 0004

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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