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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Cohort | Experimental | Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences |
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| High Dose Cohort | Experimental | Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Administered orally as a tablet or capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Apparent oral clearance (CL/F) | Predose and up to 48 hours postdose up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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| Up to approximately 6 months |
| Number of participants with clinically significant electrocardiogram (ECG) results | 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 | Up to approximately 6 months |