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Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIRB 796 BS, low dose | Experimental |
| |
| BIRB 796 BS, high dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BIRB 796 BS, medium dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIRB 796 BS, low dose | Drug |
| ||
| BIRB 796 BS, high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically significant changes in vital signs | up to 21 days | |
| Number of patients with clinically significant changes in laboratory parameters | up to 21 days | |
| Number of patients with abnormal findings in electrocardiogram | up to 21 days | |
| Number of patients with adverse events | up to 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analyte in plasma (Cmax) for several time points | up to 36 hours after dosing | |
| Area under the plasma concentration versus time curve (AUC) for several time points | up to 36 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C452139 | doramapimod |
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| Drug |
|
| Placebo | Drug |
|
| Time at which maximum plasma concentration occurred over a dosing interval (tmax) | up to 36 hours after dosing |
| Terminal elimination rate constant (λZ) | up to 36 hours after dosing |
| Elimination half-life (t1/2) | up to 36 hours after dosing |
| Mean residence time (MRT) | up to 36 hours after dosing |
| Apparent oral clearance (CL/F) | up to 36 hours after dosing |
| Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F) | up to 36 hours after dosing |