Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

Study Overview
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Brief Summary
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This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 144807 Placebo
* Drug: BI 144807


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI144807<br>Subjects receive a single oral dose of BI144807solution | Drug: BI 144807<br>* single dose (low to high dose)<br>|
| Placebo Comparator: Placebo<br>Subjects receive a single oral dose of placebo solution | Drug: BI 144807 Placebo<br>* Placebo that represents BI drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events |  | up to 14 days postdose | 
| Number of participants with clinically significant changes in vital signs |  | up to 14 days postdose | 
| Number of participants with clinically significant changes in ECG |  | up to 14 days postdose | 
| Number of participants with clinically significant changes in laboratory tests |  | up to 14 days postdose | 
| Number of participants with clinically significant changes in physical examination |  | up to 14 days postdose | 
| Number of participants tolerating BI 144807 |  | up to 14 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 72h postdose | 
| tmax (time from dosing to maximum measured concentration) |  | up to 72h postdose | 
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 72h postdose | 
| AUC(0-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 72h postdose | 
| t1/2 (terminal half-life of the analyte in plasma) |  | up to 72h postdose |