A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

Inclusion Criteria

1. Healthy males or females, ages 18 to 55 years, inclusive, at the time of informed
consent.

2. Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.

3. Females must not be lactating or pregnant at Screening or Baseline.

4. Females of childbearing potential must not have had unprotected sexual intercourse
within 30 days before study entry and must agree to use a highly effective method of
contraception (eg, total abstinence, a doublebarrier method [such as condom plus
diaphragm with spermicide], have a vasectomized partner with confirmed azoospermia,
or an intrauterine device, contraceptive implant, or oral contraceptive that does not
contain levogesterol) throughout the entire study period and for 30 days after study
drug discontinuation. Females using hormonal contraceptives containing levogesterol
must be on another form of contraception (such as double barrier method.) as well. If
currently abstinent, the subject must agree to use a doublebarrier method as
described above if she becomes sexually active during the study period or for 30 days
after study drug discontinuation. Females who are using hormonal contraceptives must
have been on a stable dose of the same hormonal contraceptive product for at least 4
weeks before dosing and must continue to use the same contraceptive during the study
and for 30 days after study drug discontinuation. All females will be considered to
be of childbearing potential unless they are postmenopausal (amenorrheic for at least
12 consecutive months, in the appropriate age group, and without other known or
suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation,
total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month
before dosing).

Exclusion Criteria

1. Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical attention within 4 weeks of
dosing.

2. Evidence of disease that may influence the outcome of the study within 4 weeks of
dosing, eg, psychiatric disorders and disorders of the gastrointestinal tract, liver,
kidney, respiratory system, endocrine system, hematological system, neurological
system, cardiovascular system, or subjects who have a congenital abnormality in
metabolism.

3. Any history of gastrointestinal surgery that may affect PK profiles of perampanel,
eg, hepatectomy, nephrotomy, cholecystectomy, digestive organ resection or any
gastrointestinal procedure for the purpose of weight loss (including Lapband), which
would slow gastric emptying.

4. 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 or Baseline.

5. Any laboratory abnormalities considered clinically significant by the investigator.

6. A prolonged QT/QTc interval (QTc greater than 450 msec) as demonstrated upon repeat
ECG at Screening or Baseline

7. History of prolonged QT/QTc interval.

8. History of risk factors for torsade de pointes (eg, heart failure, hypokalemia,
family history of long QT syndrome).

9. History of ischemic heart disease (eg, acute coronary syndromes, stable angina),
syncope or cardiac arrhythmias.

10. Siting heart rate less than 40 or greater than 100 beats/min at Screening or Baseline
Period 1 and sitting systolic blood pressure greater than 140 mmHg or less than 90
mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at
Screening or Baseline.

11. Hemoglobin less than 11.5 g/dLfor females and less than 12.5 g/dL for males at screen
and Baseline check-in Period 1.

12. Subjects who experienced a weight loss or gain of greater than 10% between Screening
and before dosing.

13. Subjects who received blood products within 4 weeks, donated blood within 8 weeks, or
donated plasma within 1 week of dosing.

14. Hypersensitivity to the study drug or any of its excipients.

15. Known history of food allergies or presently experiencing significant seasonal or
perennial allergy at Screening.

16. Known to be human immunodeficiency virus (HIV) positive at Screening.

17. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening.

18. History of use of illegal (or legalized) recreational drugs in the past year.

19. History of drug or alcohol dependency or abuse within approximately the last 2 years
or who have a positive urine drug test or breath alcohol test at Screening or
Baseline.

20. Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners,
weight lifters).

21. Currently enrolled in another clinical trial or used any investigational drug or
device within 30 days preceding informed consent.