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Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-BIRB 796 BS | Drug | 14C-radiolabeled BIRB 796 BS |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose) | up to 5 days | |
| Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose) | up to 5 days | |
| Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma | up to 96 hours after drug administration | |
| Area under the Concentration versus time curve from time 0 to infinity (AUC0-∞) of 14C-BIRB 796BS in plasma | up to 96 hours after drug administration | |
| Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma | up to 96 hours after drug administration | |
| Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma | up to 96 hours after drug administration | |
| Erythrocyte-plasma partition ratio of 14C-radioactivity | up to 5 days | |
| Cmax of 14C-BIRB 796BS in blood | up to 96 hours after drug administration | |
| AUC0-∞ of 14C-BIRB 796BS in blood | up to 96 hours after drug administration | |
| tmax of 14C-BIRB 796BS in blood | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Excretion of 14C-radioactivity in saliva (percent of dose) | up to 24 hours after drug administration | |
| Excretion of 14C-radioactivity in expired air (percent of dose) | up to 48 hours after drug administration |
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Exclusion Criteria:
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| t1/2 of 14C-BIRB 796BS in blood | up to 96 hours after drug administration |
| Cmax of BIRB 796BS in plasma | up to 96 hours after drug administration |
| AUC0-∞ of BIRB 796BS in plasma | up to 96 hours after drug administration |
| tmax of BIRB 796BS in plasma | up to 96 hours after drug administration |
| t1/2 of BIRB 796BS in plasma | up to 96 hours after drug administration |
| Quantification of radiolabeled metabolites in urine (percent of dose) | up to 5 days |
| Quantification of radiolabeled metabolites in feces (percent of dose) | up to 5 days |
| Quantification of radiolabeled metabolites in plasma (percent of dose) | up to 96 hours after drug administration |