Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
- Registration Number
- NCT05767398
- Lead Sponsor
- BeiGene
- Brief Summary
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Body mass index between 18.0 and 32.0 kg/m^2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)
Exclusion Criteria
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
- Evidence of any infections (bacterial, viral, fungal, parasitic, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
- History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
- Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >upper limit of normal (ULN) range
- Positive hepatitis panel and/or positive human immunodeficiency virus test
Note: Other protocol defined Inclusion/Exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 Zanubrutinib Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. Sequence 1 Zanubrutinib Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Predose and up to 48 hours postdose up to Day 10 Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) Predose and up to 48 hours postdose up to Day 10 Apparent volume of distribution (Vz/F) Predose and up to 48 hours postdose up to Day 10 Rate of decrease of concentration in the terminal phase (λz) Predose and up to 48 hours postdose up to Day 10 Time of the maximum observed plasma concentration (Tmax) Predose and up to 48 hours postdose up to Day 10 Apparent oral clearance (CL/F) Predose and up to 48 hours postdose up to Day 10 Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) Predose and up to 48 hours postdose up to Day 10 Apparent terminal elimination half-life (t1/2) Predose and up to 48 hours postdose up to Day 10
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 30 days after last dose; up to approximately 7 weeks Number of participants with clinically significant laboratory values Up to 30 days after last dose; up to approximately 7 weeks Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
Number of participants with clinically significant electrocardiogram (ECG) results Up to 30 days after last dose; up to approximately 7 weeks Number of participants with clinically significant vital sign measurements Up to 30 days after last dose; up to approximately 7 weeks Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit
🇺🇸Dallas, Texas, United States