A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.
详细描述
This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 44 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
Cohort 1 to 7
Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition.
干预措施: E6130 (Drug)
Cohort 1 to 7
Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition.
干预措施: Placebo (Drug)
Cohort 8
Participants will receive a single dose of E6130 (determined in Cohort 1 to 7), administered in the specified order (fed/fasted or fasted/fed) to evaluate the food effect.
干预措施: E6130 (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
时间窗: Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8)
次要结局
- Area under the serum concentration-time curve from time zero to infinity (AUC(0-inf)) of E6130(Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8))
- Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) of E6130(Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8))
- Apparent terminal phase half-life (t1/2) of E6130(Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8))
- Maximum observed serum concentration (Cmax) of E6130(Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8))
- Time to Cmax (Tmax) of E6130(Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8))