A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
研究概览
简要总结
The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males of any race, between 18 and 65 years of age, inclusive.
- •Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening
- •Must have a body mass index (BMI) between 18 and 32 kg/m^2
排除标准
- •Participants with a clinically relevant history or presence of any clinically significant disease
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
- •History of drug or alcohol abuse within 1 year prior to check-in
- •Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
- •Use of tobacco- or nicotine-containing products within 3 months prior to check-in
- •Use or intended use of any prescription medications/products within 14 days prior to check-in
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib + Rifabutin
Day 1: zanubrutinib
Days 3 to 10: rifabutin
Day 11: zanubrutinib and rifabutin
干预措施: Zanubrutinib (Drug)
Zanubrutinib + Rifabutin
Day 1: zanubrutinib
Days 3 to 10: rifabutin
Day 11: zanubrutinib and rifabutin
干预措施: Rifabutin (Drug)
结局指标
主要结局
Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Apparent Oral Clearance (CL/F) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Apparent Volume of Distribution (Vz/F) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
次要结局
- Number of Participants Experiencing Adverse Events (AEs)(From the date of first study drug administration to 30 days after last dose (up to 3.5 months))