Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups and Open-label for the Active Controls)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- measured glomerular filtration rate (mGFR) based on renal iohexol clearance
研究概览
简要总结
Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 40 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
Naproxen
干预措施: Naproxen (Drug)
Cimetidine
干预措施: Cimetidine (Drug)
BI 1060469 low dose
Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
干预措施: Placebo (Drug)
BI 1060469 low dose
Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
干预措施: BI 1060469 low dose (Drug)
BI 1060469 high dose
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
干预措施: Placebo (Drug)
BI 1060469 high dose
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
干预措施: BI 1060469 high dose (Drug)
BI 1021958
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
干预措施: Placebo (Drug)
BI 1021958
High-Dose,Tablets,oral administration with 240 ml water, over 10 days
干预措施: BI 1021958 (Drug)
结局指标
主要结局
measured glomerular filtration rate (mGFR) based on renal iohexol clearance
时间窗: up to day 11
次要结局
- measured urinary 24-hour creatinine clearance(up to day 11)