A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults
Not Applicable
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT07141511
- Lead Sponsor
- BeiGene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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.
- An absolute B-cell count of >200 cells/μL.
- 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) within 4 weeks prior to the first dose of study drug, as determined by the investigator (or designee).
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BG-71332, Zanubrutinib + Sonrotoclax BG-71332 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. BG-71332, Zanubrutinib + Sonrotoclax Zanubrutinib 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. BG-71332, Zanubrutinib + Sonrotoclax Sonrotoclax 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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 Up to 30 days after last dose, up to approximately 47 days Laboratory parameters include hematology, clinical chemistry, and urinalysis test results