Healthy Volunteers
Conditions
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.
Interventions
DRUGBG-71332
Administered orally
DRUGZanubrutinib
Administered orally
DRUGSonrotoclax
Administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
Australia
Contacts
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed