jRCT2071200055尚未招募不适用
Safety, tolerability and pharmacokinetics of single and multiple rising doses of BI 764198 in Japanese healthy male subjects (double-blind, randomised, placebo-controlled within dose groups, parallel group design)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- -
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
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age 0month 0week old over 至 45age 0month 0week old under（—）
- 性别
- Male
入选标准
- •Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
结局指标
主要结局
-
Percentage of subjects with drug-related adverse events
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
A study in healthy Japanese men to test how well different doses of BI 1291583 are toleratedjRCT2071210111Nippon Boehringer Ingelheim Co., Ltd.36
进行中（未招募）
不适用
A study in healthy Japanese men to test how well different doses of BI 3006337 are toleratedNon-alcoholic SteatohepatitisjRCT2031230638Boehringer Ingelheim36
已完成
不适用
A study in healthy Japanese men to test how well different doses
of BI 1569912 are toleratedjRCT2071210037Nippon Boehringer Ingelheim Co., Ltd.44
已完成
不适用
A study in healthy Japanese men to test how well different doses of BI 765845 are toleratedjRCT2031230092Boehringer Ingelheim32
已完成
不适用
A study in healthy Japanese men to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the bloodjRCT2071200056Nippon Boehringer Ingelheim Co., Ltd.74