A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase I Trial in Healthy Male Current Smoker Subjects to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response and Safety of 4 Weeks Oral Administration of BI 1026706
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
研究概览
简要总结
The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.
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
- 性别
- All
- 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 1026706
干预措施: BI 1026706 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
时间窗: Day 29
Total cell count of neutrophils in Bronchoalveolar Lavage (BAL) fluid after 24 hours of the segmental Lipopolysaccharide (LPS) challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the Least Square (LS) means obtained by fitting an Analysis of variance (ANOVA) model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
次要结局
- Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.(Day 29)
- Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge(Day 29)
- Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.(Day 29)
- Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge(Day 29)
- Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge(Day 29)
- Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.(Day 29)
- Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge(Day 29)
- Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.(Day 29)
- Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.(Day 29)