Healthy
Conditions
Brief summary
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
Interventions
DRUGBIIL 284 oral solution
DRUGBIIL 284 wetability improved formulation (WIF) tablets
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Terminal half-life (t1/2) | up to 72 hours after drug administration | — |
| Total mean residence time (MRTtot) | up to 72 hours after drug administration | — |
| Changes in white blood cell count | up to 48 hours after drug administration | determined by flow cytometer |
| 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 | — |
| Changes in differential blood cell count | up to 48 hours after drug administration | determined by flow cytometer |
| 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 | — |
Outcome results
None listed