Clinical trial NCT03424564: Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects
Official title: A Single and Multiple Dose Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Perampanel
Pharmacokinetics
E2007
Chinese
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for the time at which the highest drug concentration occurs (tmax) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for area under the concentration-time curve from zero time to 24 hours (AUC[0-24h]) postdose of perampanel
timeFrame: 0-24 hours postdose
measure: 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
timeFrame: 0-336 hours postdose
measure: 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
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for the terminal phase rate constant (λz) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for terminal elimination phase half-life (t1/2) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for apparent total clearance following oral administration (CL/F) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean value for the apparent volume of distribution at terminal phase (Vz/F) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Single-dose Part: Mean residence time (MRT) postdose of perampanel
timeFrame: 0-336 hours postdose
measure: Multiple-dose Part: Mean value of Cmax postdose of perampanel on Day 1
timeFrame: 0-24 hours postdose on Day 1
measure: Multiple-dose Part: Mean minimum observed concentration (Cmin) postdose of perampanel on Day 1
timeFrame: 0-24 hours postdose on Day 1
measure: Multiple-dose Part: Mean tmax postdose of perampanel on Day 1
timeFrame: 0-24 hours postdose on Day 1
measure: Multiple-dose Part: Mean AUC(0-24h) postdose of perampanel on Day 1
timeFrame: 0-24 hours postdose on Day 1
measure: Multiple-dose Part: Mean value of area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])
timeFrame: 0-24 hours postdose of perampanel on Day 21
measure: Multiple-dose Part: Mean value of the average steady-state concentration (Css,av) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of the maximum observed concentration at steady state (Css,max) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of the minimum observed concentration at steady state (Css,min) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of peak-trough fluctuation (PTF) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean time at which the highest drug concentration occurs at steady state (tss,max) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: 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
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of t1/2 postdose of perampanel on Day 21
timeFrame: 0-336 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of apparent total clearance following oral administration at steady state (CLss/F) postdose of perampanel on Day 21
timeFrame: 0-24 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of Vz/F postdose of perampanel on Day 21
timeFrame: 0-336 hours postdose on Day 21
measure: Multiple-dose Part: Mean value of the accumulation ratio
timeFrame: 0-24 hours postdose of perampanel on Days 1 and 21
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Eisai Trial Site
state: Beijing
Study officials:
References: