Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

Study Overview
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Brief Summary
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The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers

Official Title
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Randomised 3-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Tablet C and Tablet D in Comparison to WIF Tablet in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIL 284 BS tablet C
* Drug: BIIL 284 BS tablet D
* Drug: BIIL 284 BS WIF tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants are healthy males Age range from 21 to 50 years Broca-Index: within +- 20% of their normal weight In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study Exclusion Criteria: Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders Volunteers with history of orthostatic hypotension, fainting spells or blackouts Volunteers with chronic or relevant acute infections Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Volunteers who have taken a drug with a long half-life (>= 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study Volunteers who participated in another study with an investigational drug within the last two months preceding this study Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day) Volunteers who drink more than 60g of alcohol per day Volunteers who are dependent on drugs Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study Volunteers who have donated blood within the last 4 weeks (>= 100 mL)

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 |
| --- | --- |
| Experimental: BIIL 284 BS tablet C<br> | Drug: BIIL 284 BS tablet C<br> <br> |
| Experimental: BIIL 284 BS tablet D<br> | Drug: BIIL 284 BS tablet D<br> <br> |
| Active Comparator: BIIL 284 BS WIF tablet<br> | Drug: BIIL 284 BS WIF tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 72 hours after drug administration | 
| Cmax (Maximum measured concentration of the analyte in plasma) |  | up to 72 hours after drug administration | 
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) |  | up to 72 hours after drug administration | 
| t½ (Terminal half-life of the analyte in plasma) |  | up to 72 hours after drug administration | 
| MRTtot (Total mean residence time) |  | up to 72 hours after drug administration | 
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) |  | up to 72 hours after drug administration | 
| CLtot/F (Total clearance after oral administration) |  | up to 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 8 days after last drug administration | 
| Number of subjects with clinically findings in vital functions | blood pressure, pulse rate, ECG | up to 8 days after last drug administration | 
| Number of subjects with clinically findings in laboratory tests |  | up to 8 days after last drug administration |