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

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

Recruiting
18-75 years
All
Phase 1

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Overview

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

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 details
    Hepatic Impairment
    Healthy Volunteers

NCT06535399

Celgene

12 September 2025

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