A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-5475 in Healthy Japanese and Caucasian Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MSD K.K.
- 入组人数
- 48
- 主要终点
- Vital signs
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
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese or Caucasian male participants between the ages of 20 and 45 years (inclusive) with a BMI less than or equal to 30 kg/m2.
排除标准
- •Has a history of clinically significant abnormalities or diseases.
结局指标
主要结局
Vital signs
Vital signs following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
Physical examinations
Physical examinations following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
12-lead electrocardiograms
12-lead electrocardiograms following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
Safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis)
Safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
Adverse events
Adverse events following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants
次要结局
- Cmax(Multiple dose part)
- AUC0-inf(Multiple dose part)
- AUC0-24(Multiple dose part)
- t1/2(Multiple dose part)
- Tmax(Multiple dose part)
- accumulation ratio based on Cmax(Multiple dose part)
- accumulation ratio based on AUC0-24(Multiple dose part)