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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Specified dose on specified days
Local Institution - 0003
Chandler, Arizona, United States
Local Institution - 0002
Miami Lakes, Florida, United States
Local Institution - 0001
Orlando, Florida, United States
Maximum observed concentration (Cmax)
Time frame: Up to Day 44
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 44
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 44
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 44
Number of participants with adverse events (AEs)
Time frame: Up to Day 60
Number of participants with serious adverse events (SAEs)
Time frame: Up to Day 60
Number of participants with physical examination (PE) abnormalities
Time frame: Up to Day 44
Number of participants with vital sign abnormalities
Time frame: Up to Day 44
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 44
Number of participants with clinical safety laboratory abnormalities
Time frame: Up to Day 44
Dialysate clearance of golcadomide from plasma (CLD)
Time frame: Day 1
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