NCT02676830已完成1 期
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
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
- 13
- 主要终点
- Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
研究概览
简要总结
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent before any study-specific evaluation is performed.
- •Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.
- •Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.
排除标准
- •Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- •Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-
- •Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.
研究组 & 干预措施
K-312
Experimental
干预措施: K-312 100 mg (Drug)
K-312
Experimental
干预措施: K-312 100 ug C14 IV (Drug)
结局指标
主要结局
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
时间窗: 336 hours post-dose
Area under the plasma-concentration time curve to last measured time point
时间窗: 336 hours post-dose
次要结局
未报告次要终点
研究者
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