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

NCT ID: NCT03399734

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2018-03-09

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment A

4 milligrams (mg) perampanel tablet

Group Type: EXPERIMENTAL

Perampanel

Intervention Type: DRUG

Single oral dose of 1 x 4-mg perampanel tablet

Treatment B

4 mg perampanel fine granules

Group Type: EXPERIMENTAL

Perampanel

Intervention Type: DRUG

Single 4-mg dose of perampanel fine granules

Interventions

Perampanel

Single oral dose of 1 x 4-mg perampanel tablet

Intervention Type: DRUG

Perampanel

Single 4-mg dose of perampanel fine granules

Intervention Type: DRUG

Other Intervention Names

E2007; E2007

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site

Toshima-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

E2007-J081-053

Identifier Type: -

Identifier Source: org_study_id