Status:
RECRUITING
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
Lead Sponsor:
Celgene
Conditions:
Hepatic Impairment
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 par...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 12 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06535399
Start Date
August 15 2024
End Date
November 12 2025
Last Update
November 12 2025
Active Locations (6)
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1
Local Institution - 0001
Chandler, Arizona, United States, 85225
2
Local Institution - 0004
Chandler, Arizona, United States, 85225
3
Local Institution - 0002
Orlando, Florida, United States, 32809
4
Local Institution - 0005
Orlando, Florida, United States, 32809