A single-dose study in healthy Japanese male adults to evalaute pharmacokinetics and pharmacodynamics of E5501 5 mg tablet

Eisai Co., Ltd.0 个研究点目标入组 15 人开始时间: 2013年2月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Non-smokers aged 20-44 at the time of informed consent,
•2. BMI is between 18.5 kg/m2 and below 25 kg/m2 at screening,
•3. Platelet count is between 120000/microliter and below 300000/microliter at screening and baseline,
•4. Subjects and their partners can agree to use medically appropriate contraception through the study period,
•5. Voluntarily provided written informed cosent,
•6. Willing and able to comply with the protocol

•1. With a past or present history of arterial thrombosism venous thrombosis or thrombophilia,
•2. 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,
•3. With a past surgical history that may affect the pharmacokinetics of E5501,
•4. Suspected to have a clinically abnormal symptom or organ dysfunction that requires treatment based on the past history, compliations, subjective and objective symptms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline,
•5. QTcF > 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline

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