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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
Who can join
Ages 18 to 84 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME). * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study * 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 * Other protocol-defined inclusion/exclusion criteria apply.
About the study
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.
What is being tested
- Golcadomide (drug)
Sponsor: Bristol-Myers Squibb · Participants: 30 · Started: Sep 8, 2026
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07763418
Locations in the U.S.
| Arizona | Arizona Clinical Trials - Chandler, Chandler |
| Florida | Panax Clinical Research, Miami Lakes Orlando Clinical Research Center OCRC, Orlando |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.