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

A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: perampanel; Drug: perampanel

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3 x 2-mg perampanel	Drug: perampanel; 3 x 2 mg perampanel once per day; Drug: perampanel; 6 mg perampanel once per day
Active Comparator: 6mg perampanel	Drug: perampanel; 3 x 2 mg perampanel once per day; Drug: perampanel; 6 mg perampanel once per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test),	8 days
AUC(0-t) of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test)	8 days
AUC(0-inf) of 6 x 2-mg perampanel tablets (ref) compared to that of the 12-mg perampanel tablet (test)	8 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of AEs	8 days

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Principal Investigator: Robert Cooper, Eisai Medical Services

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 4, 2012
• Last Update Submitted That Met QC Criteria: May 2, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Central Nervous System
• Other Study ID Numbers: E2007-A001-039