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

NCT01396590 | Completed Phase 1

• 1 other identifier: E2007-A001-040
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Central Nervous System

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The incidence of AEs

  8 days

Study Arms (2)

6 x 2 mg perampanel

ACTIVE COMPARATOR

Drug: Perampanel

12 mg Perampanel

ACTIVE COMPARATOR

Drug: Perampanel

Interventions

Perampanel DRUG

6 x 2 mg perampanel once per day

6 x 2 mg perampanel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Subjects who have taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
• 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)
• 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
• 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
• 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
• 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
• Subjects who have a history of drug abuse or dependence or have a positive result from a urine drug screening test
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Unknown Facility

Fargo, North Dakota, United States

Location

MeSH Terms

Interventions

perampanel

Study Officials

• Robert Cooper

  Eisai Medical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 19, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 4, 2012

Record last verified: 2012-04

Locations

US (1)