Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: perampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396577

E2007-A001-039

Details and patient eligibility

About

The purpose of this study is to determine that three 2-mg tablets of perampanel are bioequivalent to one 6-mg tablet of perampanel.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. Healthy male or female subjects, age 18 to 55 years old, inclusive, at Screening
2. Body mass index (BMI) of 18 to 32 kg/m^2, inclusive, at Screening

Exclusion:

1. Subjects who are taking any prescribed or over-the-counter drug or herbal remedies in the 2 weeks prior to Screening (unless the OTC drug has a long halflife [i.e., 5 x 1/2 greater than 2 weeks]) with the exception of acetaminophen (up to 4 g/day), which is allowed up to 12 hours prior to dosing
2. Subjects who have taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
3. Subjects who have taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, apple or Seville orange products)
4. Subjects who have received any experimental drug within the 12 weeks leading up to the start of study drug treatment or who are currently enrolled in another clinical trial
5. Subjects with a known or suspected history of alcohol abuse within the 6 months prior to Screening or who have a positive urine drug test or breath alcohol test at Screening or Baseline, or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement
6. Subjects who consume more than 5 caffeinated beverages per day (e.g., 5 cups of tea, coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the periods of in-patient confinement
7. Subjects who smoke more than 5 cigarettes (or equivalent amount of tobacco) per day or who are unwilling to abstain from the use of nicotine-containing products throughout the period of in-patient confinement
8. Subjects who have a history of drug abuse or dependence or have a positive result from a urine drug screening test
9. Women of child-bearing potential who do not agree to use 2 methods of adequate contraception (e.g., intrauterine device, barrier methods with spermicide) throughout the study and for 30 days after study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

3 x 2-mg perampanel

Active Comparator group

Treatment:

Drug: perampanel

6mg perampanel

Active Comparator group

Treatment:

Drug: perampanel