临床试验/NCT03424564

NCT03424564已完成1 期

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

Eisai Co., Ltd.1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2018年3月20日最近更新: 2018年8月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eisai Co., Ltd.
入组人数: 44
试验地点: 1
主要终点: Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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

研究组 & 干预措施

Perampanel single-dose Part: 2 mg group

Experimental

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

干预措施: Perampanel (Drug)

Perampanel single-dose Part: 4 mg group

Experimental

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

干预措施: Perampanel (Drug)

Perampanel single-dose Part: 8 mg group

Experimental

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

干预措施: Perampanel (Drug)

Perampanel multiple-dose Part

Experimental

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.

干预措施: Perampanel (Drug)

结局指标

主要结局

Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel

时间窗: 0-336 hours postdose

Single-dose Part: Mean value for the time at which the highest drug concentration occurs (tmax) postdose of perampanel

时间窗: 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

时间窗: 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

时间窗: 0-336 hours postdose

Single-dose Part: Mean value for apparent total clearance following oral administration (CL/F) postdose of perampanel

时间窗: 0-336 hours postdose

Single-dose Part: Mean value for the apparent volume of distribution at terminal phase (Vz/F) postdose of perampanel

时间窗: 0-336 hours postdose

Single-dose Part: Mean residence time (MRT) postdose of perampanel

时间窗: 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

时间窗: 0-336 hours postdose

Single-dose Part: Mean value for the terminal phase rate constant (λz) postdose of perampanel

时间窗: 0-336 hours postdose

Single-dose Part: Mean value for terminal elimination phase half-life (t1/2) postdose of perampanel

时间窗: 0-336 hours postdose

Multiple-dose Part: Mean value of Cmax postdose of perampanel on Day 1

时间窗: 0-24 hours postdose on Day 1

Multiple-dose Part: Mean minimum observed concentration (Cmin) postdose of perampanel on Day 1

时间窗: 0-24 hours postdose on Day 1

Multiple-dose Part: Mean tmax postdose of perampanel on Day 1

时间窗: 0-24 hours postdose on Day 1

Multiple-dose Part: Mean AUC(0-24h) postdose of perampanel on Day 1

时间窗: 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])

时间窗: 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