Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Fortrea Cru, Daytone Beach
Daytona Beach, Florida, United States
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Maximum Observed Concentration (Cmax)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Time of the Maximum Observed Concentration (Tmax)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Total Clearance (CL/F)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Volume of Distribution (Vz/F)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Number of Participants with Adverse Events (AEs)
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant laboratory values
Time frame: Approx 38 days in Part 1 and 45 days in part 2
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Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant vital sign measurements
Time frame: Approx 38 days in Part 1 and 45 days in part 2