An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: Elimination of E2609: urine/feces concentration
研究概览
简要总结
This is an open-label, single dose study in healthy male subjects.
详细描述
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
- greater than 90% of the administered radioactivity has been recovered, and
- less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
干预措施: E2609 (Drug)
结局指标
主要结局
Pharmacokinetics: Elimination of E2609: urine/feces concentration
时间窗: Predose and every 24 hours postdose up to 28 days
Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
Pharmacokinetics: Plasma concentration of E2609/metabolite
时间窗: Predose andup to 648 hours postdose
Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
次要结局
- Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration(Predose andup to 648 hours postdose)