A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
Recruitment temporarily on hold due to COVID-19
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Specified Dose on Specified Days
Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research
Saint Paul, Minnesota, United States
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Time frame: Day 1 and Day 8
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Time frame: Day 1 and Day 8
Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
Time frame: Day 1 and Day 8
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Time frame: Day 1 and Day 8
Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)
Time frame: Day 8
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Time frame: Day 8
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Time frame: Day 8
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Time frame: Day 8
Terminal elimination half-life of BMS-986259 (T-HALF)
Time frame: Day 8
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Time frame: Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
Time frame: Day 8
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Incidence of Non serious Adverse Events (AEs)
Time frame: Up to 4 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 months
Incidence of AEs leading to discontinuation
Time frame: Up to 4 months
Number of clinically significant changes in vital signs
Time frame: Up to 4 months
Number in clinically significant changes in Electrocardiogram (ECG)
Time frame: Up to 4 months
Number of clinically significant changes in physical examinations
Time frame: Up to 4 months
Number of clinically significant changes in clinical laboratory tests
Time frame: Up to 4 months