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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-11-12

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Impairment Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: BMS-986369 Moderate Hepatic Impairment

Group Type EXPERIMENTAL

BMS-986369

Intervention Type DRUG

Specified dose on specified days

Group B: BMS-986369 Severe Hepatic Impairment

Group Type EXPERIMENTAL

BMS-986369

Intervention Type DRUG

Specified dose on specified days

Group C: BMS-986369 Normal Hepatic Function

Group Type EXPERIMENTAL

BMS-986369

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986369

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Golcadomide

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes