Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

Study Overview
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Brief Summary
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Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.

Official Title
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A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Zanubrutinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. | Drug: Zanubrutinib<br>* Administered as a tablet or capsule<br>* Other names: Brukinsa;|
| Experimental: Sequence 2<br>Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. | Drug: Zanubrutinib<br>* Administered as a tablet or capsule<br>* Other names: Brukinsa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Time of the maximum observed plasma concentration (Tmax) |  | 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 | 
| 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 | 
| Apparent oral clearance (CL/F) |  | Predose and up to 48 hours postdose up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Laboratory values are based on hematology, clinical chemistry, and urinalysis test results | Up to 30 days after last dose; up to approximately 7 weeks | 
| 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 | Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature | Up to 30 days after last dose; up to approximately 7 weeks |