Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

October 26, 2018 updated by: Eisai Co., Ltd.

A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Toshima-ku, Tokyo, Japan
        • Eisai Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

Participants must meet all of the following criteria to be included in this study:

  • Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.
  • Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

  • Females who are breastfeeding or pregnant at Screening or Baseline
  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
  • Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
  • Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
  • 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
  • A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment A
4 milligrams (mg) perampanel tablet
Drug: Perampanel
Single oral dose of 1 x 4-mg perampanel tablet
Other Names:
  • E2007
Drug: Perampanel
Single 4-mg dose of perampanel fine granules
Other Names:
  • E2007
EXPERIMENTAL: Treatment B
4 mg perampanel fine granules
Drug: Perampanel
Single oral dose of 1 x 4-mg perampanel tablet
Other Names:
  • E2007
Drug: Perampanel
Single 4-mg dose of perampanel fine granules
Other Names:
  • E2007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time at which the highest drug concentration occurs (tmax)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Lag time (tlag)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
tlag is the time delay between drug administration and the onset of drug absorption.
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])
Time Frame: 0-72 hours postdose of Treatment Period 1 and Treatment Period 2
0-72 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal phase rate constant (λz)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal elimination phase half-life (t1/2)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Mean residence time (MRT)
Time Frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2017

Primary Completion (ACTUAL)

March 9, 2018

Study Completion (ACTUAL)

March 9, 2018

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 9, 2018

First Posted (ACTUAL)

January 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2007-J081-053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on Perampanel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe