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
| Registry | NCT06535399 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 29 (Actual) |
| Sponsor | Celgene (Industry) |
| Conditions | Hepatic Impairment, Healthy Volunteers |
| Interventions | BMS-986369 (Drug) |
| Dates | start 2024-08-15, primary completion 2025-11-12, completion 2025-11-12, first posted 2024-08-02, last updated 2026-01-23 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Hepatic Impairment All trials for Healthy Volunteers All trials of BMS-986369
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Local Institution - 0001 | Chandler, Arizona | United States | |
| Local Institution - 0002 | Orlando, Florida | United States | |
| Texas Liver Institute | San Antonio, Texas | United States |