Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
NCT ID: NCT06535399
Last Updated: 2025-11-12
Study Results
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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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2024-08-15
2025-11-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: BMS-986369 Moderate Hepatic Impairment
BMS-986369
Specified dose on specified days
Group B: BMS-986369 Severe Hepatic Impairment
BMS-986369
Specified dose on specified days
Group C: BMS-986369 Normal Hepatic Function
BMS-986369
Specified dose on specified days
Interventions
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BMS-986369
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Chandler, Arizona, United States
Local Institution - 0004
Chandler, Arizona, United States
Local Institution - 0002
Orlando, Florida, United States
Local Institution - 0005
Orlando, Florida, United States
Local Institution - 0006
San Antonio, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Eric Lawitz, Site 0003
Role: primary
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA073-1028
Identifier Type: -
Identifier Source: org_study_id