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This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel - Group 1 | Experimental | Treatment A: Single oral dose of a 12-mg perampanel tablet under fasted condition. Treatment B: Single 12 mg dose of perampanel oral suspension under fasted condition. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment A or Treatment B. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. |
|
| Perampanel - Group 2 | Experimental | Treatment C: Single oral dose of a 12-mg perampanel tablet co-administered with high fat meal. Treatment D: Single 12 mg dose of perampanel oral suspension co-administered with high fat meal. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment C or Treatment D. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Perampanel: AUC(0-t) | Up to 504 hours postdose in each treatment period | |
| Pharmacokinetics of Perampanel: AUC(0-inf) | Up to 504 hours postdose in each treatment period | |
| Pharmacokinetics of Perampanel: Cmax | Up to 504 hours postdose in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Perampanel: AUC(0-72h) | Up to 504 hours postdose in each treatment period | |
| Pharmacokinetics of Perampanel: tmax | Up to 504 hours postdose in each treatment period | |
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Inclusion Criteria
Exclusion Criteria
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| Pharmacokinetics of Perampanel: tlag |
| Up to 504 hours postdose in each treatment period |
| Pharmacokinetics of Perampanel: Lambda-z | Up to 504 hours postdose in each treatment period |
| Pharmacokinetics of Perampanel: t1/2 | Up to 504 hours postdose in each treatment period |
| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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