Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers

Study Overview
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Brief Summary
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food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Official Title
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Randomised 3-way Cross-over Phase I Study to Investigate the Effect of Different Food Compositions (Low Fat and High Fat Meal) on Bioavailability of BIIL 284 BS 75 mg Tablet in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIL 284 BS
* Other: high fat meal
* Other: low fat meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial) Participation in another trial with an investigational drug (<= two months prior to administration or during the trial) Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (> 60 g/day) Drug abuse Blood donation (>= 100 ml within four weeks prior to administration or during the trial) Excessive physical activities (within the last week before the study) Any laboratory value outside the reference range of clinical relevance

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: BIIL 284 BS fasted<br> | Drug: BIIL 284 BS<br> <br> |
| Experimental: BIIL 284 BS with high fat meal<br> | Drug: BIIL 284 BS<br> <br> Other: high fat meal<br> <br> |
| Experimental: BIIL 284 BS with low fat meal<br> | Drug: BIIL 284 BS<br> <br> Other: low fat meal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | up to 72 hours after drug administration | 
| Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity) |  | up to 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (tmax) |  | up to 72 hours after drug administration | 
| Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz) |  | up to 72 hours after drug administration | 
| Terminal half-life (t1/2) |  | up to 72 hours after drug administration | 
| Total mean residence time (MRTtot) |  | up to 72 hours after drug administration | 
| Volume of distribution during terminal phase after oral administration (Vz/F) |  | up to 72 hours after drug administration | 
| Total clearance after oral administration (CLtot/F) |  | up to 72 hours after drug administration | 
| Number of subjects with adverse events |  | up to 8 days after last drug administration | 
| Number of subjects with clinically significant findings in vital functions | blood pressure, pulse rate, ECG | up to 8 days after last drug administration | 
| Number of subjects with clinically significant findings in laboratory tests |  | up to 8 days after last drug administration |