NCT00824057已完成1 期
A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
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
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
研究概览
简要总结
The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.
排除标准
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
- •Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
研究组 & 干预措施
1
Experimental
干预措施: AZD6280 (Drug)
1
Experimental
干预措施: Midazolam (Drug)
1
Experimental
干预措施: Caffeine (Drug)
结局指标
主要结局
To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
时间窗: Blood samples will be taken throughout the 19-day inpatient period of the study.
次要结局
- To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.(Observations taken post dosing.)
- Evaluation of the pharmacodynamic effects of AZD6280(Test batteries will be performed before and following study drug administration.)
- To evaluate the pharmacokinetics of AZD6280(Blood samples will be taken throughout the 19-day inpatient period of the study.)
研究者
研究点 (1)
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