NCT02044627已完成1 期
A Phase 1, Open-Label,Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 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
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Level of [14C]-ETC-1002 in urine and feces after a single dose
研究概览
简要总结
This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of [14C]-ETC-1002
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 Volunteers
- •BMI 10-35 kg/m2
排除标准
- •Hx of CV, renal, hepatic, chronic respiratory or GI disease
- •Hx of drug or alcohol abuse
- •smoking within 12 mos of screening
研究组 & 干预措施
1 dose of [14C-ETC-1002]
Experimental
干预措施: [14C-ETC-1002] (Drug)
结局指标
主要结局
Level of [14C]-ETC-1002 in urine and feces after a single dose
时间窗: 11 days
using mass balance recovery
次要结局
未报告次要终点
研究者
研究点 (1)
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