A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
研究概览
简要总结
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
详细描述
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI)18 - 32 kg/m2, inclusive.
- •Subjects of Asian (first- or second-generation) and non-Asian descent.
- •In good general health as assessed by the Investigator.
- •Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
- •Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days after the last dose of BGB-3111.Able to comprehend and willing to sign consent.
排除标准
- •Subjects with a clinically relevant history or presence of any clinically significant disease.
- •Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- •History of alcoholism or drug/chemical abuse within prior year.
研究组 & 干预措施
Arm A
Approximately 20 subjects to receive BGB-3111 and rifampin
干预措施: BGB-3111 (Arm A) (Drug)
Arm A
Approximately 20 subjects to receive BGB-3111 and rifampin
干预措施: Rifampin (Drug)
Arm B
Approximately 20 subjects to receive BGB-3111 and itraconazole
干预措施: BGB-3111 (Arm B) (Drug)
Arm B
Approximately 20 subjects to receive BGB-3111 and itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
时间窗: Part A: Days 1 and 10
Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
时间窗: Part B: Days 1 and 6
次要结局
- Safety as assessed by adverse events(Part A: up to 19 days: Part B: up to 14 days)
- Safety as assessed by electrocardiogram (ECG) measurements(Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14)