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

Celgene

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteers

Treatments: Drug: BMS-986369

Study type: Interventional

Funder types: Industry

Identifiers

NCT06535399

CA073-1028

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Group A: BMS-986369 Moderate Hepatic Impairment

Experimental group

Treatment:

Drug: BMS-986369

Group B: BMS-986369 Severe Hepatic Impairment

Experimental group

Treatment:

Drug: BMS-986369

Group C: BMS-986369 Normal Hepatic Function

Experimental group

Treatment:

Drug: BMS-986369