Healthy
Conditions
Brief summary
To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects as determined by results of screening * Signed written informed consent in accordance with good clinical practice (GCP) and local legislation * Age \>= 18 and \<= 45 years * Broca \>= -20% and \<= +20%
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 * Surgery of gastrointestinal tract (except appendectomy) * 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 ot the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24 hours) (= 1 month prior to administration or during the trial) * Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial) * Participation in another trial with an investigational drug (=2 months prior to administration or during trial) * Smoker (\> 10 cigarettes of \> 3 cigars of \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation \> 400 ml (=1 month prior to administration of during the trial) * Excessive physical activities (= 5 days prior to administration or during the trial) * Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count \>= 10 x 10\*\*9/L, C-reactive protein \>= 4.5 mg/L, any haemoglobin or \> 15 mg/dl protein on urine dipstick * History of any familial bleeding disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with clinically relevant changes in vital signs | Baseline, up to 96 hours after drug administration |
| Number of subjects with clinically relevant changes in laboratory measurements | Baseline, up to 96 hours after drug administration |
| Number of subjects with clinically relevant changes in electrocardiograms (ECG) | Baseline, up to 96 hours after drug administration |
| Number of subjects with adverse events | up to 96 hours after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance of the analyte in plasma (CL/F) | up to 96 hours after drug administration | — |
| Apparent volume of distribution during the terminal phase λz (Vz/F) | up to 48 hours after drug administration | — |
| Maximum concentration of the analyte in plasma (Cmax) | up to 48 hours after drug administration | — |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | up to 48 hours after drug administration | — |
| Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils | up to 48 hours after drug administration | — |
| Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils | up to 48 hours after drug administration | — |
| Percent changes in TNFalpha production | up to 48 hours after drug administration | after ex vivo stimulation of whole blood with endotoxin |
| Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf) | up to 48 hours after drug administration | — |
| Terminal rate constant of the analyte in plasma (λz) | up to 48 hours after drug administration | — |
| Half life of the analyte in plasma (t1/2) | up to 48 hours after drug administration | — |
| Mean residence time of the analyte in the body (MRTtot) | up to 48 hours after drug administration | — |
Outcome results
None listed