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Completed

NCT Number: NCT03424564

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eisai Trial Site

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perampanel

Drug

Oral Tablet

Other names: E2007

Primary outcomes

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

  3. Single-dose Part: Mean value for area under the concentration-time curve from zero time to 24 hours (AUC[0-24h]) postdose of perampanel

    Time frame: 0-24 hours postdose

  4. 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

    Time frame: 0-336 hours postdose

  5. 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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-336 hours postdose

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

    Time frame: 0-24 hours postdose on Day 1

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

    Time frame: 0-24 hours postdose on Day 1

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

    Time frame: 0-24 hours postdose on Day 1

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

    Time frame: 0-24 hours postdose on Day 1

  15. Multiple-dose Part: Mean value of area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])

    Time frame: 0-24 hours postdose of perampanel on Day 21

  16. Multiple-dose Part: Mean value of the average steady-state concentration (Css,av) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  17. Multiple-dose Part: Mean value of the maximum observed concentration at steady state (Css,max) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  18. Multiple-dose Part: Mean value of the minimum observed concentration at steady state (Css,min) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  19. Multiple-dose Part: Mean value of peak-trough fluctuation (PTF) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  20. Multiple-dose Part: Mean time at which the highest drug concentration occurs at steady state (tss,max) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  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

    Time frame: 0-24 hours postdose on Day 21

  22. Multiple-dose Part: Mean value of t1/2 postdose of perampanel on Day 21

    Time frame: 0-336 hours postdose on Day 21

  23. Multiple-dose Part: Mean value of apparent total clearance following oral administration at steady state (CLss/F) postdose of perampanel on Day 21

    Time frame: 0-24 hours postdose on Day 21

  24. Multiple-dose Part: Mean value of Vz/F postdose of perampanel on Day 21

    Time frame: 0-336 hours postdose on Day 21

  25. Multiple-dose Part: Mean value of the accumulation ratio

    Time frame: 0-24 hours postdose of perampanel on Days 1 and 21

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2018
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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