Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. |
|
| Sequence 2 | Experimental | Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Administered as a tablet or capsule |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |