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This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Experimental |
|
| Group B | Experimental | Days 1-14: Multiple oral dose of 2 mg perampanel (one 2 mg tablet) Days 15-28: Multiple oral dose of 4 mg perampanel (two 2 mg tablets) Days 29-42: Multiple oral dose of 6 mg perampanel (three 2 mg tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | 2 mg up to 4 mg |
| |
| Perampanel |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of perampanel in Korean healthy male subjects | PK analysis will be performed on PK Analysis Set using plasma concentrations of perampanel. Plasma concentrations will be tabulated by nominal sampling time and summarized using summary statistics. | Approximately 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of perampanel | Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, weight, physical examinations and electrocardiograms (ECGs). | Approximately 56 days |
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Inclusion Criteria
Subjects who meet all of the following criteria will be included in the study:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from participation in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| Drug |
2 mg up to 6 mg |
|