About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Golcadomide
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Maximum observed concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Secondary outcomes
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with physical examination (PE) abnormalities
Number of participants with vital sign abnormalities
Sponsors and contacts
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