Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Perampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424564

E2007-C086-052

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Perampanel single-dose Part: 2 mg group

Experimental group

Description:

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

Treatment:

Drug: Perampanel

Perampanel single-dose Part: 4 mg group

Experimental group

Description:

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

Treatment:

Drug: Perampanel

Perampanel single-dose Part: 8 mg group

Experimental group

Description:

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

Treatment:

Drug: Perampanel

Perampanel multiple-dose Part

Experimental group

Description:

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.

Treatment:

Drug: Perampanel