jRCT1080225285已完成1 期
A Phase I Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-S-600918 Following Oral Dose Administration in Healthy Adult Male Subjects
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
- Total radioactivity (TR) in all excreta
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single-centre, open-label, single arm
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 30age old over 至 65age old under（—）
- 性别
- Male
入选标准
- •Healthy male subjects
排除标准
- •Subjects who are considered ineligible for this study by the investigator or subinvestigator due to current or history of clinically significant metabolic or endocrine, cardiovascular, renal, hepatic, hematological, urological, immunological, pulmonary, respiratory or gastrointestinal disease, neurological or psychiatric disorderor, or other clinically significant diseases.
结局指标
主要结局
Total radioactivity (TR) in all excreta
- Cumulative amount of TR excreted in excreta (CumAe) - CumAe expressed as a percentage of the radioactive dose administered (Cum%Ae)
Pharmacokinetics (PK) parameters for TR, S-600918 and S-600918 acyl glucuronide
PK parameters in plasma for TR in whole blood including but not limited to: - time to maximum concentration (Tmax) - maximum concentration (Cmax) - area under the concentration-time curve (AUC)
次要结局
- pharmacokinetics
- whole blood:plasma concentration ratios
- metabolite analysis
- adverse events
研究者
研究点 (1)
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