A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions
研究概览
简要总结
E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Non-smokers aged 20-44 at the time of informed consent,
- •BMI is between 18.5 kg/m2 and below 25 kg/m2 at screening,
- •Platelet count is between 120,000/ microliter and below 300,000/ microliter at screening and baseline
- •Subjects and their partners can agree to use medically appropriate contraception through the study period
- •Voluntarily provided written informed consent
- •Willing and able to comply with the protocol
排除标准
- •With a past or present history of arterial thrombosis, venous thrombosis or thrombophilia
- •With a past history of clinically significant disease within 8 weeks before study drug administration or clinically significant infection within 4 weeks before study drug administration
- •With a past surgical history that may affect the pharmacokinetics of E5501
- •Suspected to have a clinically abnormal symptom or organ dysfunction that requires treatment based on the past history, complications, subjective and objective symptoms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline
- •QTcF greater than 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline
研究组 & 干预措施
Group A
E5501 5mg, then 20mg, then 40 mg, then 5mg
干预措施: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg (Drug)
Group B
E5501 20mg, then 40mg, then 5 mg, then 5mg
干预措施: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg (Drug)
Group C
E5501 40mg, then 5mg, then 20 mg, then 5mg
干预措施: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg (Drug)
结局指标
主要结局
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions
时间窗: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
次要结局
未报告次要终点