The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet containing zanubrutinib and sonrotoclax (BG-71332) compared to a zanubrutinib capsule and sonrotoclax tablet administered simultaneously and the effect of food on how the body processes the fixed-dose combination tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Administered orally
Administered orally
Administered orally
Linear Early Phase
Joondalup, Western Australia, Australia
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib
Time frame: Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for sonrotoclax
Time frame: Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for zanubrutinib
Time frame: Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for sonrotoclax
Time frame: Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of zanubrutinib
Time frame: Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of sonrotoclax
Time frame: Predose and up to 72 hours post dose
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 30 days after last dose, up to approximately 47 days
Number of participants with laboratory abnormalities
Laboratory parameters include hematology, clinical chemistry, and urinalysis test results
Time frame: Up to 30 days after last dose, up to approximately 47 days
Number of participants with clinically significant abnormal electrocardiogram (ECG) values
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Time frame: Up to 30 days after last dose, up to approximately 47 days
Number of participants with clinically significant vital signs measurements
Time frame: Up to 30 days after last dose, up to approximately 47 days