The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Specified dose on specified days
Specified Dose on specified days
Local Institution - 0001
Miami, Florida, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 14
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 14
AUC from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 14
Number of participants with adverse events (AEs)
Time frame: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Time frame: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 14
Number of participants with physical examination abnormalities
Time frame: Up to Day 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 14
Geometric mean ratio of Cmax
Time frame: Up to Day 17
Geometric mean ratio of AUC(0-T)
Time frame: Up to Day 17
Geometric mean ratio of AUC(INF)
Time frame: Up to Day 17
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 17
Apparent total body clearance (CLT/F)
Time frame: Up to Day 14
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 14
Number of participants with AEs
Time frame: Up to 30 days post last scheduled visit
Number of participants with vital sign abnormalities
Time frame: Up to Day 14
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 14
Number of participants with physical examination abnormalities
Time frame: Up to Day 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 14
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