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

NCT06535399 | Completed Phase 1 FDA Drug

• 1 other identifier: CA073-1028
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Healthy Volunteers; Pharmacokinetics; Liver Diseases; Moderate and Severe Hepatic Impairment; BMS-986369; CC-99282; Hepatic Impairment; Golcadomide

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to approximately 44 days

• Time of maximum observed plasma concentration (Tmax)

  Up to approximately 44 days

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

  Up to approximately 44 days

Secondary Outcomes (6)

• Incidence of adverse events (AEs)

  Up to approximately 44 days

• Incidence of serious adverse events (SAEs)

  Up to approximately 44 days

• Number of participants with physical examination abnormalities

  Up to approximately 44 days

• Number of participants with vital sign abnormalities

  Up to approximately 44 days

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to approximately 44 days

Study Arms (3)

Group A: BMS-986369 Moderate Hepatic Impairment

EXPERIMENTAL

Drug: BMS-986369

Group B: BMS-986369 Severe Hepatic Impairment

EXPERIMENTAL

Drug: BMS-986369

Group C: BMS-986369 Normal Hepatic Function

EXPERIMENTAL

Drug: BMS-986369

Interventions

BMS-986369 DRUG

Specified dose on specified days

Also known as: Golcadomide

Group A: BMS-986369 Moderate Hepatic Impairment; Group B: BMS-986369 Severe Hepatic Impairment; Group C: BMS-986369 Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

Local Institution - 0001

Chandler, Arizona, 85225, United States

Location

Local Institution - 0002

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Liver Diseases; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 15, 2024
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)