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Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03424564
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Perampanel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single and Multiple Dose Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel

Arms and Interventions
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Arm Intervention/treatment
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
Oral Tablet
Other Name: E2007
Experimental: Perampanel single-dose Part: 4 mg group
Participants will receive a single 4 mg dose of perampanel orally under fasted conditions.
 Drug: Perampanel
Oral Tablet
Other Name: E2007
Experimental: Perampanel single-dose Part: 8 mg group
Participants will receive a single 8 mg dose of perampanel orally under fasted conditions.
 Drug: Perampanel
Oral Tablet
Other Name: E2007
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
Oral Tablet
Other Name: E2007


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424564


Locations
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China, Beijing
Eisai Trial Site
Beijing, Beijing, China
Sponsors and Collaborators
Eisai Co., Ltd.
More Information
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03424564    
Other Study ID Numbers: E2007-C086-052
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Perampanel
Pharmacokinetics
E2007
Chinese