NCT01587417已完成1 期
A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 187004 CL
Experimental
1 single dose per subject as oral solution
干预措施: BI 187004 CL (Drug)
Placebo to BI 187004 CL
Placebo Comparator
1 single dose per subject as oral solution
干预措施: Placebo to BI 187004 CL (Drug)
结局指标
主要结局
Occurrence of adverse events
时间窗: up to 15 days postdose
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(up to 96 hours postdose)
- AUC0-8 (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)(up to 96 hours postdose)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 96 hours postdose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XXHealthyNCT01587391Boehringer Ingelheim48
已完成
1 期
Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy VolunteersDiabetes Mellitus, Type 2NCT01146886Boehringer Ingelheim60
终止
1 期
A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal HypertensionPortal HypertensionNCT02929407Ferring Pharmaceuticals4
已完成
1 期
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy ParticipantsHealthyNCT05428696Alexion Pharmaceuticals, Inc.90
招募中
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult SubjectsHealthy Adult SubjectsNCT06635226IlDong Pharmaceutical Co Ltd36