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CompletedNCT03424564Updated Aug 28, 2018

Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

A Phase 1 interventional study of Perampanel in Healthy Subjects, sponsored by Eisai Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Perampanel
  • Pharmacokinetics
  • E2007
  • Chinese
03

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.

Browse Eisai Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Perampanel single-dose Part: 2 mg group

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

    Drug: Perampanel

  • Experimental
    Perampanel single-dose Part: 4 mg group

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

    Drug: Perampanel

  • Experimental
    Perampanel single-dose Part: 8 mg group

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

    Drug: Perampanel

  • Experimental
    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.

    Drug: Perampanel

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Eisai Trial Site
    Beijing, Beijing Municipality, China
08

References and documents

Publications

  • Jing S, Shiba S, Morita M, Yasuda S, Lin Y. A Single- and Multiple-Dose Pharmacokinetic Study of Oral Perampanel in Healthy Chinese Subjects. Clin Drug Investig. 2023 Mar;43(3):155-165. doi: 10.1007/s40261-022-01241-8. Epub 2023 Feb 6. PubMed 36746851 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in May 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 7, 2018
StartActual
Mar 20, 2018
Primary completionActual
May 25, 2018
CompletionActual
May 25, 2018
Last update
Aug 28, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03424564
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Mar 20, 2018
Primary completion
May 25, 2018
Completion
May 25, 2018
Last update
Aug 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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