Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

Official Title
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A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Perampanel
* Drug: Perampanel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants must meet all of the following criteria to be included in this study: Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing. Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening Exclusion Criteria Participants who meet any of the following criteria will be excluded from this study: Females who are breastfeeding or pregnant at Screening or Baseline Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>4 milligrams (mg) perampanel tablet | Drug: Perampanel<br>* Single oral dose of 1 x 4-mg perampanel tablet<br>* Other names: E2007;|
| Experimental: Treatment B<br>4 mg perampanel fine granules | Drug: Perampanel<br>* Single 4-mg dose of perampanel fine granules<br>* Other names: E2007;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h]) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which the highest drug concentration occurs (tmax) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Lag time (tlag) | tlag is the time delay between drug administration and the onset of drug absorption. | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h]) |  | 0-72 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t]) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Terminal phase rate constant (λz) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Terminal elimination phase half-life (t1/2) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 
| Mean residence time (MRT) |  | 0-168 hours postdose of Treatment Period 1 and Treatment Period 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perampanel, Bioequivalence, fine granules, E2007, Japanese