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Healthy SubjectsPhase 1NCT03424564

Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

A Phase 1 study testing Perampanel in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Perampanel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
20 Mar 2018to 25 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Eisai Trial Site

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Single and Multiple Dose 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.

Being tested
Perampanel
Keywords
Perampanel, Pharmacokinetics, E2007, Chinese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerampanelDrug

    Also called E2007

    Oral Tablet

Study groups in NCT03424564
Study groupRoleWhat they receive
Perampanel single-dose Part: 2 mg groupExperimentalParticipants will receive a single 2 milligrams (mg) dose of perampanel orally under fasted conditions.
Receives: Drug: Perampanel
Perampanel single-dose Part: 4 mg groupExperimentalParticipants will receive a single 4 mg dose of perampanel orally under fasted conditions.
Receives: Drug: Perampanel
Perampanel single-dose Part: 8 mg groupExperimentalParticipants will receive a single 8 mg dose of perampanel orally under fasted conditions.
Receives: Drug: Perampanel
Perampanel multiple-dose PartExperimentalParticipants 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.
Receives: Drug: Perampanel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 0-336 hours postdose

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 0-336 hours postdose

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

    Measured: 0-336 hours postdose

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

    Measured: 0-336 hours postdose

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

    Measured: 0-336 hours postdose

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

    Measured: 0-336 hours postdose

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

    Measured: 0-336 hours postdose

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

    Measured: 0-24 hours postdose on Day 1

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

    Measured: 0-24 hours postdose on Day 1

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

    Measured: 0-24 hours postdose on Day 1

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

    Measured: 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])

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 0-24 hours postdose on Day 21

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

    Measured: 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

    Measured: 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

    Measured: 0-24 hours postdose on Day 21

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

    Measured: 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

    Measured: 0-24 hours postdose on Day 21

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

    Measured: 0-336 hours postdose on Day 21

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start20 Mar 2018
  3. Primary completion25 May 2018
  4. Study completion25 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424564
Sponsor's protocol ID
E2007-C086-052
Status last verified
Jun 2018
First submitted
1 Feb 2018
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Perampanel in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single-dose Part: Mean value of the maximum observed concentration (Cmax) postdose of perampanel (time frame: 0-336 hours postdose). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424564, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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