A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4482 in Healthy Japanese Adult Participants(COVID-19)

MSD K.K.0 个研究点目标入组 72 人开始时间: 2021年4月12日最近更新: 2022年3月17日

试验速览

阶段: 不适用
状态: 已完成
发起方: MSD K.K.
入组人数: 72
主要终点: Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Single Assignment
主要目的: Other
盲法: Double Blind

入排标准

年龄范围: 20age old over 至 60age old under（—）
性别: Male

入选标准

•Healthy Japanese male between the ages of 20 and 60 years with BMI of 18.5 to 24.9 kg/m2

排除标准

•Has a history of clinically significant abnormalities or diseases.

结局指标

主要结局

Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations

Following a single or multiple oral doses of MK-4482

Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine in plasma

Following a single oral dose of MK-4482

Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine

Following multiple oral doses of MK-4482

次要结局

AUC0-inf and Cmax of N-hydroxycytidine in plasma
Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells
Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells

研究者

发起方

MSD K.K.

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