NCT00832169已完成1 期
An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to 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
- 6
- 试验地点
- 1
- 主要终点
- Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
研究概览
简要总结
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
- •Healthy volunteer must have regular bowel movements (at least once daily)
排除标准
- •History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
- •A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
- •Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
研究组 & 干预措施
1
Experimental
干预措施: AZD1386 (Drug)
结局指标
主要结局
Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
时间窗: Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta
时间窗: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h
次要结局
- AZD1386 metabolites in plasma+excreta if feasable(Predose, 1h, 4h, 8h 24h)
- Safety + tolerability of AZD1386(Predose, 2h, 6h, 12h, 24h, 48h, 168h)
研究者
研究点 (1)
Loading locations...
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