NCT00866385已完成1 期
An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers
适应症
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
- 21
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
研究概览
简要总结
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Provision of written informed consent
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- •Females who are permanently or surgically sterile or post-menopausal and males
排除标准
- •History of any convulsions or seizures
- •History of infection or risk of infection due to recent surgery or trauma
- •History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug
结局指标
主要结局
Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
时间窗: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
次要结局
- Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events(Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events.)
- Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose(Samples taken during visit 2, at up to 40 defined timepoints pre and post dose)
- Intravenous pharmacokinetics(Samples taken during visit 2, at up to 40 defined timepoints pre and post dose)
研究者
研究点 (1)
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