Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1026706; Drug: Placebo

• Registration Number: NCT02657408
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Study Start: 2016-03-11
• Primary Completion: 2017-02-14
• Study Completion: 2017-03-13
• Results First Submitted: 2018-12-17
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1026706	BI 1026706	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge	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 Outcome Measures

Name	Time	Method
Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.	Day 29	Differential cell count of eosinophil in BAL fluid 24 h after segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge	Day 29	Total cell count of macrophage+monocyte BAL fluid after 24 hours of the segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.; Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.
Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.	Day 29	Differential cell count of neutrophils in BAL fluid 24 h after segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge	Day 29	Total cell count of monocyte in BAL fluid after 24 hours of the segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.
Total Cell Count of Eosinophil 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.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.	Day 29	Differential cell count of monocyte (determined by flow cytometry) in BAL fluid 24 h after segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.; Monocyte cell count is the only cell count which was assessed by means of flow cytometry.
Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge	Day 29	Total cell count of lymphocyte after 24 hours of the segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.	Day 29	Differential cell count of lymphocyte in BAL fluid 24 h after segmental LPS challenge.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Differential Cell Count of Macrophage+Monocyte 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.; The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.; Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.

Trial Locations

Locations (1)

Fraunhofer ITEM; 🇩🇪 Hannover, Germany