Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Official Title
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Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 135585
* Drug: BI 135585


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - healthy male subjects Exclusion criteria: - 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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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 135585 (T)<br>single dose per subject as tablet formulation after high fat, high caloric meal | Drug: BI 135585<br>* one oral single dose per subject<br>|
| Experimental: BI 135585 (R)<br>single dose per subject as tablet formulation after an overnight fast | Drug: BI 135585<br>* one oral single dose per subject<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 BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity |  | up to 144 hours post treatment | 
| Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity |  | up to 144 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-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 144 hours post treatment | 
| Physical examination (occurrence of findings) |  | up to 14 days post treatment | 
| %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation) |  | up to 144 hours post treatment | 
| tmax (time from dosing to maximum measured concentration) |  | up to 144 hours post treatment | 
| λz (terminal rate constant in plasma) |  | up to 144 hours post treatment | 
| t1/2 (terminal half-life of the analyte in plasma) |  | up to 144 hours post treatment | 
| MRTpo (mean residence time of the analyte in the body after oral administration) |  | up to 144 hours post treatment | 
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) |  | up to 144 hours post treatment | 
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) |  | up to 144 hours post treatment | 
| Vital signs (blood pressure, pulse rate) |  | up to 14 days post treatment | 
| 12-lead ECG (electrocardiogram) |  | up to 14 days post treatment | 
| Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis) |  | up to 14 days post treatment | 
| Incidence and severity of Adverse events |  | up to 14 days post treatment | 
| Assessment of tolerability by the investigator |  | up to 14 days post treatment |