NCT03561298已完成1 期
An Open-label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple Doses of Zanubrutinib With a Drug "Cocktail" Representative for CYP3A4, CYP2C9, CYP2C19, P-gP and BCRP Substrates
BeiGene1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
研究概览
简要总结
This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
- •Subjects must have a body mass index (BMI) between 18 and 32 kg/m
- •Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.
排除标准
- •Subjects 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 2 years prior to Check-In.
- •Alcohol consumption of >21 units per week.
- •A positive urine drug screen and/or positive alcohol breath test at Screening and/or 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.
- •History of blood donation of 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
研究组 & 干预措施
Single Arm: BGB-3111 + Drug Cocktail
Experimental
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
干预措施: BGB-3111 and Drug Cocktail (Drug)
结局指标
主要结局
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
时间窗: Days 1-20
Time of the maximum observed plasma concentration (Tmax)
次要结局
- Number of participants with adverse events as a measure of safety and tolerability.(up to 26 days)
研究者
研究点 (1)
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