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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

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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