Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

A Single and Multiple Dose Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

This study will be conducted to evaluate the pharmacokinetics of perampanel following single and multiple oral doses in Chinese healthy male and female participants.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Perampanel

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Eisai Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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:

• Chinese healthy adult volunteers (males and females)
• Non-smoking, male or female age ≥18 years and ≤45 years old at the time of obtaining written consent. To be considered non-smokers, participants must have discontinued smoking from screening before first dosing.
• Participants with a Body Mass Index ≥18.5 and <24.5 kilograms per meters squared at screening
• Participants who undergo screening within 3 weeks before study treatment and are confirmed to be eligible by the investigator

Exclusion Criteria:

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

• Participants who weigh less than 50 kilograms
• Females who are breastfeeding or pregnant at Screening or Baseline
• Females of childbearing potential
• 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/corrected QT (QTc) interval (QTc interval for heart rate using Fredericia's formula >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perampanel single-dose Part: 2 mg group; Participants will receive a single 2 milligrams (mg) dose of perampanel orally under fasted conditions.	Drug: Perampanel; Oral Tablet; Other Names: E2007
EXPERIMENTAL: Perampanel single-dose Part: 4 mg group; Participants will receive a single 4 mg dose of perampanel orally under fasted conditions.	Drug: Perampanel; Oral Tablet; Other Names: E2007
EXPERIMENTAL: Perampanel single-dose Part: 8 mg group; Participants will receive a single 8 mg dose of perampanel orally under fasted conditions.	Drug: Perampanel; Oral Tablet; Other Names: E2007
EXPERIMENTAL: Perampanel multiple-dose Part; Participants will receive multiple oral dose of perampanel (2 milligrams per day [mg/day] from Day 1 to Day 7 and 4 mg/day from Day 8 to Day 21). Fasted condition is required for Days 1 and 21.	Drug: Perampanel; Oral Tablet; Other Names: E2007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for the time at which the highest drug concentration occurs (tmax) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for area under the concentration-time curve from zero time to 24 hours (AUC[0-24h]) postdose of perampanel	0-24 hours postdose
Single-dose Part: Mean value for area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t]) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for the terminal phase rate constant (λz) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for terminal elimination phase half-life (t1/2) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for apparent total clearance following oral administration (CL/F) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean value for the apparent volume of distribution at terminal phase (Vz/F) postdose of perampanel	0-336 hours postdose
Single-dose Part: Mean residence time (MRT) postdose of perampanel	0-336 hours postdose
Multiple-dose Part: Mean value of Cmax postdose of perampanel on Day 1	0-24 hours postdose on Day 1
Multiple-dose Part: Mean minimum observed concentration (Cmin) postdose of perampanel on Day 1	0-24 hours postdose on Day 1
Multiple-dose Part: Mean tmax postdose of perampanel on Day 1	0-24 hours postdose on Day 1
Multiple-dose Part: Mean AUC(0-24h) postdose of perampanel on Day 1	0-24 hours postdose on Day 1
Multiple-dose Part: Mean value of area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])	0-24 hours postdose of perampanel on Day 21
Multiple-dose Part: Mean value of the average steady-state concentration (Css,av) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean value of the maximum observed concentration at steady state (Css,max) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean value of the minimum observed concentration at steady state (Css,min) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean value of peak-trough fluctuation (PTF) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean time at which the highest drug concentration occurs at steady state (tss,max) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean time at which the lowest drug concentration between dosing intervals occurs at steady state (tss,min) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean value of t1/2 postdose of perampanel on Day 21	0-336 hours postdose on Day 21
Multiple-dose Part: Mean value of apparent total clearance following oral administration at steady state (CLss/F) postdose of perampanel on Day 21	0-24 hours postdose on Day 21
Multiple-dose Part: Mean value of Vz/F postdose of perampanel on Day 21	0-336 hours postdose on Day 21
Multiple-dose Part: Mean value of the accumulation ratio	0-24 hours postdose of perampanel on Days 1 and 21

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): May 25, 2018
• Study Completion (ACTUAL): May 25, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Chinese; Pharmacokinetics; Perampanel; E2007
• Other Study ID Numbers: E2007-C086-052

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