Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGZanubrutinib
Administered orally as a tablet or capsule
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee * Female participants of non-childbearing potential only
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) 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 * Use or intent to use prescription medications within 14 days prior to dosing or nonprescription medications/products/supplements within 7 days prior to check-in * Use of tobacco or nicotine containing products within 3 months prior to check-in Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent oral clearance (CL/F) | Predose and up to 48 hours postdose up to Day 7 |
| Time of the maximum observed plasma concentration (Tmax) | Predose and up to 48 hours postdose up to Day 7 |
| Apparent terminal elimination half-life (t1/2) | Predose and up to 48 hours postdose up to Day 7 |
| Apparent volume of distribution (Vz/F) | Predose and up to 48 hours postdose up to Day 7 |
| Rate of decrease of concentration in the terminal phase (λz) | Predose and up to 48 hours postdose up to Day 7 |
| 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 7 |
| 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 7 |
| Maximum observed plasma concentration (Cmax) | Predose and up to 48 hours postdose up to Day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant laboratory values | Up to approximately 6 months | Laboratory values are based on hematology, clinical chemistry, and urinalysis test results |
| Number of participants with clinically significant electrocardiogram (ECG) results | Up to approximately 6 months | — |
| Number of participants with clinically significant vital sign measurements | Up to approximately 6 months | Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature |
| Number of participants with adverse events (AEs) | Up to approximately 6 months | — |
Countries
United States
Outcome results
None listed