Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
43
Administered orally as a tablet or capsule
Fortrea Clinical Research Unit
Dallas, Texas, United States
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Predose and up to 48 hours postdose up to Day 7
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Time frame: Predose and up to 48 hours postdose up to Day 7
Maximum observed plasma concentration (Cmax)
Time frame: Predose and up to 48 hours postdose up to Day 7
Time of the maximum observed plasma concentration (Tmax)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent terminal elimination half-life (t1/2)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent volume of distribution (Vz/F)
Time frame: Predose and up to 48 hours postdose up to Day 7
Rate of decrease of concentration in the terminal phase (λz)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent oral clearance (CL/F)
Time frame: Predose and up to 48 hours postdose up to Day 7
Number of participants with adverse events (AEs)
Time frame: Up to approximately 6 months
Number of participants with clinically significant laboratory values
Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to approximately 6 months
Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Up to approximately 6 months
Number of participants with clinically significant vital sign measurements
Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature
Time frame: Up to approximately 6 months