Clinical Trials in the USA / NCT07763418
Recruiting
Phase 1
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
NCT07763418 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Kidney Failure, Chronic
Investigational drug(s) / intervention(s)
Golcadomide: Specified dose on specified days
Study 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
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.
Primary outcome measure(s)
- Maximum observed concentration (Cmax) — Up to Day 44
- Time of maximum observed plasma concentration (Tmax) — Up to Day 44
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) — Up to Day 44
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) — Up to Day 44
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Clinical Trials - Chandler | Chandler | Arizona | Recruiting |
| Panax Clinical Research | Miami Lakes | Florida | Recruiting |
| Orlando Clinical Research Center OCRC | Orlando | Florida | Recruiting |
More Bristol-Myers Squibb trials in the USA
A Rollover Study of CC-122
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07763418 on ClinicalTrials.gov ↗ ← All trials in the USA