Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01396590
First received: July 13, 2011
Last updated: May 2, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine that six 2-mg tablets of perampanel are bioequivalent to one 12-mg tablet of perampanel.


Condition Intervention Phase
Healthy
Drug: Perampanel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • AUC(0-t) of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • AUC(0-inf) of 6 x 2-mg perampanel tablets (ref) compared to that of the 12-mg perampanel tablet (test) [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of AEs [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6 x 2 mg perampanel Drug: Perampanel
6 x 2 mg perampanel once per day
Active Comparator: 12 mg Perampanel Drug: Perampanel
12 mg perampanel once per day

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396590

Locations
United States, North Dakota
Fargo, North Dakota, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Robert Cooper Eisai Medical Services
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01396590     History of Changes
Other Study ID Numbers: E2007-A001-040
Study First Received: July 13, 2011
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Central Nervous System

ClinicalTrials.gov processed this record on August 19, 2014