Golcadomide pharmacokinetics and safety in severe kidney impairment and ESRD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial sponsored by Bristol-Myers Squibb. It compares golcadomide pharmacokinetics and safety among adults with severe renal impairment, those with end-stage renal disease, and healthy controls with normal renal function. Participants receive Golcadomide and undergo PK sampling, safety assessments, and laboratory monitoring to characterize drug exposure and tolerability. Inclusion criteria specify adults 18–84 with BMI 18–40, including healthy controls and patients with RI or ESRD; key exclusions address conditions that could affect drug absorption or immune status. The study aims to inform dosing considerations across renal function groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Arizona Clinical Trials - Chandler
  Chandler, Arizona, United States Recruiting
• Panax Clinical Research
  Miami Lakes, Florida, United States Recruiting
• Orlando Clinical Research Center OCRC
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.