Clinical Trial: NCT06535399
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Celgene |
| Information Provided By: | Celgene |
| Last Update Posted: | 2026-01-23 |
Study Overview
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.
Official Title
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
Conditions
Hepatic Impairment, Healthy Volunteers
Intervention / Treatment
- Drug: BMS-986369
Other Study ID Numbers
- CA073-1028
Start Date (Actual)
2024-08-15
Primary Completion Date (Actual)
2025-11-12
Study Completion Date (Actual)
2025-11-12
Enrollment (Actual)
29
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Celgene |
| Information Provided By: | Celgene |
| Last Update Posted: | 2026-01-23 |
Study Overview
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.
Official Title
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
Conditions
Hepatic Impairment, Healthy Volunteers
Intervention / Treatment
- Drug: BMS-986369
Other Study ID Numbers
- CA073-1028
Start Date (Actual)
2024-08-15
Primary Completion Date (Actual)
2025-11-12
Study Completion Date (Actual)
2025-11-12
Enrollment (Actual)
29
Study Type
Interventional
Phase
Phase 1