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
Overview
- Phase
- Phase 1
- Intervention
- BI 1026706
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 1026706
Intervention: BI 1026706
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
Time Frame: 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.
Secondary Outcomes
- 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)