An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
研究概览
简要总结
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and sign a written informed consent
- •Able and willing to comply with all study requirements
- •Healthy males or healthy females of non-childbearing potential
- •Agrees to use an adequate method of contraception
- •Body mass index (BMI) of 18.0 to 32.0 kg/m^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
排除标准
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
- •Prior treatment with sonrotoclax
- •Evidence of renal impairment at screening
- •Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
- •Current smokers and those who have smoked within the last 12 months
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •History of any drug or alcohol abuse in the past 2 years
- •Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •History of clinically significant disorders as judged by the investigator
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A: Phenytoin + Sonrotoclax
Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.
干预措施: sonrotoclax (Drug)
Part A: Phenytoin + Sonrotoclax
Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.
干预措施: Phenytoin (Drug)
Part B: Itraconazole + Sonrotoclax
Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.
干预措施: Itraconazole (Drug)
Part B: Itraconazole + Sonrotoclax
Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.
干预措施: sonrotoclax (Drug)
结局指标
主要结局
Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax
时间窗: Approximately 21 days for Part A and 11 days for Part B
次要结局
- Parts A and B: Number of Participants with Adverse Events (AEs)(From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B)