A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Plasma E6007 concentration over time period - Cmax (maximum concentration)
研究概览
简要总结
This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.
For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
50 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 (Drug)
50 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 matching placebo (Drug)
100 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 (Drug)
100 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 matching placebo (Drug)
200 mg E6007 fed condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1).
干预措施: E6007 (Drug)
200 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 (Drug)
200 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 matching placebo (Drug)
400 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 (Drug)
400 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
干预措施: E6007 matching placebo (Drug)
200 mg E6007 fed condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1).
干预措施: E6007 matching placebo (Drug)
结局指标
主要结局
Plasma E6007 concentration over time period - Cmax (maximum concentration)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)
时间窗: Up to 15 days
Safety and tolerability of E6007 as a measure of Adverse events
时间窗: Screening and up to 17 days after last administration of drug
Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))
时间窗: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)
时间窗: Up to 15 days
Plasma E6007 concentration over time period - CL/F (Apparent clearance)
时间窗: Up to 15 days
次要结局
- Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)(Up to 15 days)
- Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose(Up to 5 days)
- Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)(Up to 15 days)