NCT02408055已完成1 期
A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C-TA-8995 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
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
研究概览
简要总结
A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
排除标准
- •Clinically significant abnormalities
研究组 & 干预措施
Radiolabelled TA-8995
Experimental
干预措施: TA-8995 (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995
时间窗: 35 days
AUC of TA-8995
时间窗: 35 days
Measure the amount of radiolabelled TA-8995 recovered from urine and faeces.
时间窗: 35 days
Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995
时间窗: 35 days
Elimination of half-life of radiolabelled TA-8995
时间窗: 35 days
次要结局
- Number of adverse events(35 days)
研究者
研究点 (1)
Loading locations...
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