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food effect, relative bioavailability, pharmacokinetics, safety and tolerability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIL 284 BS fasted | Active Comparator |
| |
| BIIL 284 BS with high fat meal | Experimental |
| |
| BIIL 284 BS with low fat meal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIL 284 BS | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | up to 72 hours after drug administration | |
| Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity) | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (tmax) | up to 72 hours after drug administration | |
| Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz) | up to 72 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C424425 | amelubant |
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| high fat meal |
| Other |
|
| low fat meal | Other |
|
| Terminal half-life (t1/2) | up to 72 hours after drug administration |
| Total mean residence time (MRTtot) | 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 |
| Total clearance after oral administration (CLtot/F) | up to 72 hours after drug administration |
| Number of subjects with adverse events | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in vital functions | blood pressure, pulse rate, ECG | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after last drug administration |