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

NCT03399734 | Completed Phase 1

• 1 other identifier: E2007-J081-053
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Perampanel; Bioequivalence; fine granules; E2007; Japanese

Outcome Measures

Primary Outcomes (2)

• Maximum observed concentration (Cmax)

  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])

  0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Secondary Outcomes (8)

• Time at which the highest drug concentration occurs (tmax)

  0-168 hours postdose of Treatment Period 1 and Treatment Period 2

• Lag time (tlag)

  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])

  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])

  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])

  0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Study Arms (2)

Treatment A

EXPERIMENTAL

4 milligrams (mg) perampanel tablet

Drug: Perampanel

Treatment B

EXPERIMENTAL

4 mg perampanel fine granules

Drug: Perampanel

Interventions

Perampanel DRUG

Single oral dose of 1 x 4-mg perampanel tablet

Also known as: E2007

Treatment A

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Eisai Trial Site

Toshima-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

perampanel

Study Design

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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: December 18, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-01

Locations

JP (1)