NCT07763418PHASE1RecruitingAccepts Healthy Volunteers
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
Bristol-Myers Squibb
Start Date
9/8/2026
Completion Date
12/28/2026
Summary
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.
Eligibility Criteria
Age Range: 18 years to 84 years
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.
Interventions
DRUG
Golcadomide
Conditions
Kidney Failure, Chronic
Locations
Arizona Clinical Trials - Chandler
Chandler, Arizona 85225
United States
Panax Clinical Research
Miami Lakes, Florida 33014
United States
Orlando Clinical Research Center OCRC
Orlando, Florida 32809-3017
United States