The purpose of this study is test the safety and tolerability of BMS-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
199
Specified dose on specified days
Specified dose on specified days
Vseobecna Fakultni Nemocnice v Praze
Prague, Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia
Number of Serious Adverse Events (SAEs)
Time frame: Up to one month
Number of Adverse Events (AEs)
Time frame: Up to one month
Number of deaths
Time frame: Up to one month
Maximum observed plasma concentration (Cmax)
Time frame: Up to one month
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to one month
Terminal elimination half-life (T-HALF)
Time frame: Up to one month
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to one month
Area under the plasma concentration-time curve from time zero extrapoloated [AUC(INF)]
Time frame: Up to one month
Area under the concentration-time curve in one dosing interval [AUC(TAU)]
Time frame: Up to one month
Accumulation ratio: ratio of Cmax following last dose to Cmax following first dose (ARcmax)
Time frame: Up to one month
Accumulation ratio: ratio of AUC(TAU) following last dose to AUC(TAU) following first dose (ARtau)
Time frame: Up to one month
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Deventer Ziekenhuis
Deventer, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
PRA Health Sciences - Groningen
Groningen, Netherlands
Spaarne Gasthuis - Haarlem-Zuid
Haarlem, Netherlands
D & A Research and Genetics
Sneek, Netherlands
Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie
Lublin, Poland
4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Wroclaw, Poland
Hospital Universitario Ramon Y Cajal
Madrid, Spain
...and 8 more locations
Terminal elimination rate constant (kel)
Time frame: Up to one month
Apparent oral clearance, calculated as dose/AUC(INF) for single dose or dose/AUC(TAU) for multiple dose
Time frame: Up to one month
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Up to one month
Cumulative urinary excretion (of the unchanged drug) over one dosing interval [Ae(TAU)]
Time frame: Up to one month
Cumulative urinary excretion (of the unchanged drug) [Aet]
Time frame: Up to one month
Renal clearance (CLr)
Time frame: Up to one month
Amount excreted unchanged (%) [UR%]
Time frame: Up to one month
Ratio of Metabolite Cmax to Parent Cmax, corrected for molecular weight (MR_Cmax)
Time frame: Up to one month
Ratio of Metabolite AUC(INF) to Parent AUC(INF), corrected for molecular weight
Time frame: Up to one month
Ratio of Metabolite AUC(0-T) to Parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]
Time frame: Up to one month
Ratio of Metabolite AUC(TAU) to Parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]
Time frame: Up to one month
Drug-drug interaction (DDI) assessment
Time frame: Up to one month