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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018518-56 | EudraCT Number |
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This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Experimental | 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug | 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects. | These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices. | Approximately 14 Weeks |
| Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax) | Approximately 14 Weeks | |
| Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax) | Approximately 14 Weeks | |
| Pharmacokinetics of total radioactivity and E2007: AUC(0-24h) | Area under the concentration x time curve from time 0 to 24 hours | Approximately 14 Weeks |
| Pharmacokinetics of total radioactivity and E2007: AUC(0-t) | Area under the concentration x time curve from time 0 to time of last measurable concentration | Approximately 14 Weeks |
| Pharmacokinetics of total radioactivity and E2007: AUC(0-inf) | Area under the concentration x time curve from time 0 to infinity | Approximately 14 Weeks |
| Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2) | Approximately 14 Weeks |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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