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
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.
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.
[{"measure":"Maximum observed concentration (Cmax)","timeFrame":"Up to Day 44"},{"measure":"Time of maximum observed plasma concentration (Tmax)","timeFrame":"Up to Day 44"},{"measure":"Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))","timeFrame":"Up to Day 44"},{"measure":"Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))","timeFrame":"Up to Day 44"}]