Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

Last updated: November 1, 2024
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Primary Biliary Cholangitis

Treatment

BMS-986369

Clinical Study ID

NCT06535399
CA073-1028
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.

Eligibility Criteria

Inclusion

Inclusion Criteria for all Participants (Group A, Group B, Group C):

  • Body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.

Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):

  • Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.

  • Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria.

Inclusion Criteria for a Matched Healthy Participant (Group C):

  • Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor.

  • Participants must be free of any clinically significant disease that would interfere with the study evaluations.

Exclusion Criteria for all Participants (Group A, Group B, and Group C):

  • Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).

  • History of major surgery within 8 weeks before the study intervention administration.

  • Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: BMS-986369
Phase: 1
Study Start date:
August 15, 2024
Estimated Completion Date:
October 11, 2025

Connect with a study center

  • Arizona Liver Health

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • Local Institution - 0004

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Local Institution - 0005

    Orlando, Florida 32809
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Local Institution - 0006

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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