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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399734
• Other study ID #: E2007-J081-053
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2017
• Est. completion date: March 9, 2018

Study information

• Verified date: January 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Perampanel
Single oral dose of 1 x 4-mg perampanel tablet
• Perampanel
Single 4-mg dose of perampanel fine granules

Locations

Country	Name	City	State
Japan	Eisai Trial Site	Toshima-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Primary	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	Time at which the highest drug concentration occurs (tmax)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Secondary	Lag time (tlag)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Terminal phase rate constant (?z)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Secondary	Terminal elimination phase half-life (t1/2)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Secondary	Mean residence time (MRT)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2