The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Specified dose on specified days.
Specified dose on specified days
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States
RECRUITINGNumber of participants with treatment-emergent adverse events (AEs)
Time frame: Up to approximately Day 40
Number of participants with treatment-emergent serious adverse events (SAEs)
Time frame: Up to approximately Day 40
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Day 14
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Elimination Half-Life (T-HALF) of BMS-986521 in Plasma
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Time frame: Up to approximately Day 14
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Time frame: Up to approximately Day 14
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Time frame: Up to approximately Day 14
Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521
Time frame: Up to approximately Day 14
Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521
Time frame: Up to approximately Day 14
Geometric Mean Cmax BMS-986521 under fed and fasted conditions
Cohort 3
Time frame: Up to approximately Day 11
Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions
Cohort 3
Time frame: Up to approximately Day 11
Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions
Cohort 3
Time frame: Up to approximately Day 11
Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution
Part C
Time frame: Up to approximately Day 11
Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution
Part C
Time frame: Up to approximately Day 11
Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution
Part C
Time frame: Up to approximately Day 11