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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS oral solution | Experimental |
| |
| BIIL 284 BS WIF tablets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 oral solution | Drug |
| ||
| BIIL 284 wetability improved formulation (WIF) tablets |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C424425 | amelubant |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
| Placebo | Drug |
|
| 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 |