A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
BG-71332, Zanubrutinib + 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.
干预措施: BG-71332 (Drug)
BG-71332, Zanubrutinib + 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.
干预措施: Zanubrutinib (Drug)
BG-71332, Zanubrutinib + 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.
干预措施: Sonrotoclax (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of zanubrutinib
时间窗: Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of sonrotoclax
时间窗: Predose and up to 72 hours post dose
次要结局
- 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)