The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Intravenous infusion administration
Local Institution
Prague, Czechia
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, Poland
Specjalistyczne Centrum Medyczne Panacea Poznan
Krakow, Poland
Maximum observed plasma concentration (Cmax) derived from plasma concentration
Time frame: 11 days
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
Time frame: 11 days
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
Time frame: 11 days
Clearance (CL) derived from plasma concentration
Time frame: 11 days
Renal clearance (CLR) derived from urine concentration
Time frame: 11 days
Number of adverse events (AE)
Time frame: Up to 31 days
Number of serious adverse events (SAE)
Time frame: Up to 31 days
Terminal elimination half-life (t1/2)
Time frame: Up to 36 hours
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 36 hours
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
Time frame: Up to 36 hours
Terminal elimination phase rate constant (λz)
Time frame: Up to 36 hours
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Volume of distribution during terminal phase (Vz)
Time frame: Up to 36 hours
Fraction of administered drug excreted into urine (Fe)
Time frame: Up to 36 hours
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)
Time frame: Up to 36 hours