Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-05-25

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Perampanel single-dose Part: 2 mg group

Participants will receive a single 2 milligrams (mg) dose of perampanel orally under fasted conditions.

Group Type EXPERIMENTAL

Perampanel

Intervention Type DRUG

Oral Tablet

Perampanel single-dose Part: 4 mg group

Participants will receive a single 4 mg dose of perampanel orally under fasted conditions.

Group Type EXPERIMENTAL

Perampanel

Intervention Type DRUG

Oral Tablet

Perampanel single-dose Part: 8 mg group

Participants will receive a single 8 mg dose of perampanel orally under fasted conditions.

Group Type EXPERIMENTAL

Perampanel

Intervention Type DRUG

Oral Tablet

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.

Group Type EXPERIMENTAL

Perampanel

Intervention Type DRUG

Oral Tablet

Interventions

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Perampanel

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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E2007

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes