The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Austin, Texas, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 20
Incidence of adverse events (AEs)
Time frame: Up to day 44
Incidence of serious adverse events (SAEs)
Time frame: Up to day 44
Incidence of AEs leading to discontinuation
Time frame: Up to day 44
Number of participants with a clinically significant change from baseline in vital signs
Time frame: Up to day 21
Number of participants with a change from baseline in 12-lead ECG results
Time frame: Up to day 21
Number of participants with physical examination abnormalities
A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination
Time frame: Up to day 21
Time of maximum observed plasma concentration (Tmax)
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Time frame: Up to day 20
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to day 20
Apparent total body clearance (CLT/F)
Time frame: Up to day 20