NCT01058447已完成1 期
An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
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
- 4
- 主要终点
- Pharmacokinetic variables and Radioactivity
研究概览
简要总结
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedure
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
排除标准
- •Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
- •History or presence of any clinically significant disease or disorder in the opinion of the investigator
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
研究组 & 干预措施
1
Experimental
干预措施: AZD1981 (Drug)
结局指标
主要结局
Pharmacokinetic variables and Radioactivity
时间窗: Frequent sampling occasions during study days
次要结局
- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)(Frequent sampling occasions during study days)
研究者
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