NCT06535399CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 30 Jul 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 12 Nov 2025
- Lead sponsor
- Celgene
- NCT number
- NCT06535399
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 29
- From 15 Aug 2024 to the primary completion date, 12 Nov 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major surgery within 8 weeks before the study intervention administration.
Other illness
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.
Other
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Texas Liver Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.