NCT07763418RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
A Phase 1, Multi-center, Single-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 8 Sept 2026
- Primary completion date
- 14 Dec 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Chronic kidney disease
- NCT number
- NCT07763418
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 8 Sept 2026 to the primary completion date, 14 Dec 2026
- 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.
Other illness
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
Lab values
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
Other
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- Participant must have severe renal impairment (RI).
- Participant must have end-stage renal disease (ESRD).
- Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.
Age in the registry: 18 years to 84 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 |
|---|---|---|---|
| Arizona Clinical Trials - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| Panax Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Orlando Clinical Research Center (OCRC) Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.