Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Official Title
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An Open-label, Single Dose, Randomised, Crossover Trial in Healthy Male Subjects to Investigate the Relative Bioavailability of Tablet and Oral Solution of Two Doses of BI 144807 and Relative Bioavailability of BI 144807 When Administered as Tablet Under Fed and Fasted Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 144807 high dose
* Drug: BI 144807 intermediate dose
* Drug: BI 144807 intermediate dose
* Drug: BI 144807 intermediate dose
* Drug: BI 144807 intermediate dose
* Drug: BI 144807 intermediate dose
* Drug: BI 144807 high dose


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - Healthy male subjects Exclusion criteria: - Any relevant deviation from healthy condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 144807 PfoS Treatment A<br>intermediate dose of BI 144807 | Drug: BI 144807 intermediate dose<br>* oral solution<br>|
| Experimental: BI 144807 PfoS Treatment C<br>high dose of BI 144807 | Drug: BI 144807 high dose<br>* oral solution<br>|
| Experimental: BI 144807 Tab Treatment B<br>intermediate dose of BI 144807 | Drug: BI 144807 intermediate dose<br>* tablet<br>|
| Experimental: BI 144807 Tab Treatment D<br>high dose of BI 144807 | Drug: BI 144807 high dose<br>* tablet<br>|
| Experimental: BI 144807 Tab Treatment E<br>intermediate dose of BI 144807, fasted | Drug: BI 144807 intermediate dose<br>* tablet<br>|
| Experimental: BI 144807 Tab Treatment F<br>intermediate dose of BI 144807, fed | Drug: BI 144807 intermediate dose<br>* tablet<br>|
| Experimental: BI 144807 Tab Treatment G<br>intermediate dose of BI 144807, fasted | Drug: BI 144807 intermediate dose<br>* tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) |  | 48 hours | 
| Maximum measured concentration of the analyte in plasma (Cmax) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) |  | 48 hours |