NCT01007929终止1 期
An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile. Concentration of AZD1236 in plasma
研究概览
简要总结
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male 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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Non-smokers
排除标准
- •Subjects who are exposed to radiation exposure as part of their occupation
- •Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
- •A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc
研究组 & 干预措施
1
Experimental
14C-AZD1236
干预措施: 14C-AZD1236 (Drug)
结局指标
主要结局
Pharmacokinetic profile. Concentration of AZD1236 in plasma
时间窗: Before and after dosing
Total Radioactivity
时间窗: Before and after dosing
次要结局
- Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination(Before and after dosing)
研究者
研究点 (1)
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