This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Specified dose on specified days
Quotient Miami
Miami, Florida, United States
RECRUITINGMaximum observed concentration (Cmax)
Time frame: Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 28
Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))
Time frame: Up to Day 28
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 28
Half-life (T-HALF)
Time frame: Up to Day 28
Apparent total body clearance (CLT/F)
Time frame: Up to Day 28
Volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 28
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 35
Number of participants with Serious AEs (SAEs)
Time frame: Up to Day 35
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 28
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CONTACT
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Number of participants with vital sign abnormalities
Time frame: Up to Day 28
Number of participants with physical examination abnormalities
Time frame: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 28