What this study is
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's being tested
- Golcadomide
Intervention · DRUG
Specified dose on specified days
Study details
- Official title
- 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
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Kidney Failure, Chronic
- Enrolling
- 30 people
- Starts
- 2026-09-08
- Est. completion
- 2026-12-28
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 84 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openArizona Clinical Trials - Chandler
Chandler, Arizona, United States
- Anita Kohli, Site 0003 · Contact434-825-0921
RecruitingPanax Clinical Research
Miami Lakes, Florida, United States
- Robert Perry, Site 0002 · Contact305-698-4500
RecruitingOrlando Clinical Research Center OCRC
Orlando, Florida, United States
- Thomas Marbury, Site 0001 · Contact407-257-3462
Recruiting
Study team
Sponsor
Bristol-Myers Squibb
Study ID CA073-1033
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.