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Completed

NCT Number: NCT06535399

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986369

Drug

Specified dose on specified days

Other names: Golcadomide

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 44 days

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to approximately 44 days

  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to approximately 44 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 44 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to approximately 44 days

  3. Number of participants with physical examination abnormalities

    Time frame: Up to approximately 44 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 44 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately 44 days

  6. Number of participants with clinical safety laboratory test abnormalities

    Time frame: Up to approximately 44 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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