Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

Study Overview
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Brief Summary
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Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers

Official Title
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A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIL 284 oral solution
* Drug: BIIL 284 wetability improved formulation (WIF) tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects as determined by results of screening Age ≥ 21 and ≤ 50 years Broca ≥ - 20% and ≤ + 20% Signed written informed consent in accordance with Good Clinical Practice and local legislation Exclusion Criteria: Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders Known 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 a drug 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 Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study Participation in another study with an investigational drug within the last two months preceding this study Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day) Volunteer who is not able to refrain from smoking on study days Alcohol abuse (more than 60 g of alcohol per day) Drug abuse Excessive physical activities (e.g. competitive sports) within the last week before the study Blood donation 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIL 284 BS oral solution<br> | Drug: BIIL 284 oral solution<br> <br> |
| Experimental: BIIL 284 BS WIF tablets<br> | Drug: BIIL 284 wetability improved formulation (WIF) tablets<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clinically relevant changes in vital signs |  | up to 8 days after drug administration | 
| Number of subjects with clinically relevant changes in electrocardiogram |  | up to 8 days after drug administration | 
| Number of subjects with clinically relevant changes in laboratory parameters |  | up to 8 days after drug administration | 
| Number of subjects with adverse events |  | up to 8 days after drug administration | 
| Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1) |  | up to 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in white blood cell count | determined by flow cytometer | up to 48 hours after drug administration | 
| Changes in differential blood cell count | determined by flow cytometer | up to 48 hours after drug administration | 
| Maximum plasma concentration (Cmax) |  | up to 72 hours after drug administration | 
| Time to reach maximum plasma concentration (tmax) |  | up to 72 hours after drug administration | 
| Area under the plasma concentration-time curve (AUC) for several time intervals |  | 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 | 
| Total clearance after oral administration (CLtot/f) |  | 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 |