An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel 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
- 7
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
研究概览
简要总结
This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.
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
Perampanel
14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
干预措施: E2007 (Drug)
结局指标
主要结局
Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
时间窗: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)
时间窗: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to 24 hours
Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects.
时间窗: Approximately 14 Weeks
These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.
Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)
时间窗: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)
时间窗: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to infinity
Pharmacokinetics of total radioactivity and E2007: AUC(0-t)
时间窗: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to time of last measurable concentration
Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)
时间窗: Approximately 14 Weeks
次要结局
未报告次要终点