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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| BIBR 796 BS food effect | Experimental |
| |
| BIBR 796 BS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 796 BS | Drug |
| ||
| Placebo |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analyte in plasma (Cmax) | up to 48 hours after drug administration | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| high fat standardized breakfast | Other |
|
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | 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 |
| 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 |
| 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 | after ex vivo stimulation of whole blood with endotoxin | up to 48 hours after drug administration |