Clinical trial · Interventional
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
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
NCT06535399CI-TRIAL-00101530completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
| Hepatic Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986369 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A: BMS-986369 Moderate Hepatic Impairment
- interventionNames
- Drug: BMS-986369
- type
- EXPERIMENTAL
- label
- Group B: BMS-986369 Severe Hepatic Impairment
- interventionNames
- Drug: BMS-986369
- type
- EXPERIMENTAL
- label
- Group C: BMS-986369 Normal Hepatic Function
- interventionNames
- Drug: BMS-986369
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.