NCT00853983已完成1 期
An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male 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
- 6
- 试验地点
- 1
- 主要终点
- To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530
研究概览
简要总结
The aim of this study is to show how the body absorbs, metabolises and excretes the drug [14C]AZD0530. As for all clinical trials, safety and tolerability of the drug will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Regular Daily Bowel movements
- •Veins suitable for cannulation or repeated venepuncture
排除标准
- •Presence of any clinically significant illness
- •Abnormal vital signs
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
结局指标
主要结局
To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530
时间窗: Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose
次要结局
- To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG(From time of consent to last visit)
研究者
研究点 (1)
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