Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

Study Overview
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Brief Summary
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In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

Official Title
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Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial

Conditions
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Healthy, Asthma

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


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential) Exclusion criteria: 1. Apart from mild asthma any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 144807<br>Subjects receive multiple BID doses of BI 144807 solution | Drug: BI 144807<br>* multiple dose (bid, low to high dose)<br>|
| Placebo Comparator: Placebo<br>Subjects receive multiple BID doses of Placebo solution | Drug: Placebo to BI 144807<br>* multiple dose (bid)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (% patients) of drug-related adverse events |  | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte in plasma after first dose (Cmax) |  | up to 24 hours after first dose | 
| Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss) |  | up to 72 hours after last dose | 
| Time from first dosing to maximum measured concentration (Tmax) |  | up to 24 hours after first dose | 
| Time from last dosing to maximum measured concentration (Tmax,ss) |  | up to 72 hours after last dose | 
| Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2) |  | up to 24 hours after first dose | 
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss) |  | up to 72 hours after last dose | 
| Terminal half-life of the analyte in plasma after the first dose (t1/2) |  | up to 24 hours after first dose | 
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) |  | up to 72 hours after last dose | 
| RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose) |  | up to 72 hours after last dose | 
| RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose) |  | up to 72 hours after last dose |