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The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet containing zanubrutinib and sonrotoclax (BG-71332) compared to a zanubrutinib capsule and sonrotoclax tablet administered simultaneously and the effect of food on how the body processes the fixed-dose combination tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG-71332, Zanubrutinib + Sonrotoclax | Experimental | Participants will receive the following treatments in one of six sequences: one dose of BG-71332 with a high-fat meal, one dose of BG-71332 in a fasted state, and one dose of zanubrutinib and sonrotoclax administered together with a high-fat meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG-71332 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib | Predose and up to 72 hours post dose | |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for sonrotoclax | Predose and up to 72 hours post dose | |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for zanubrutinib | Predose and up to 72 hours post dose | |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for sonrotoclax | Predose and up to 72 hours post dose | |
| Maximum observed plasma concentration (Cmax) of zanubrutinib | Predose and up to 72 hours post dose | |
| Maximum observed plasma concentration (Cmax) of sonrotoclax | Predose and up to 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 30 days after last dose, up to approximately 47 days | |
| Number of participants with laboratory abnormalities | Laboratory parameters include hematology, clinical chemistry, and urinalysis test results |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Early Phase | Joondalup | Western Australia | WA 6027 | Australia |
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| Zanubrutinib |
| Drug |
Administered orally |
|
|
| Sonrotoclax | Drug | Administered orally |
|
|
| Up to 30 days after last dose, up to approximately 47 days |
| Number of participants with clinically significant abnormal electrocardiogram (ECG) values | Up to 30 days after last dose, up to approximately 47 days |
| Number of participants with clinically significant vital signs measurements | Up to 30 days after last dose, up to approximately 47 days |
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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