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A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02020486
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 25, 2013
Last Update Posted Date March 3, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Pharmacokinetics (PK) of perampanel in Korean healthy male subjects [ Time Frame: Approximately 56 days ]
PK analysis will be performed on PK Analysis Set using plasma concentrations of perampanel. Plasma concentrations will be tabulated by nominal sampling time and summarized using summary statistics.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
Safety and tolerability of perampanel [ Time Frame: Approximately 56 days ]
Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, weight, physical examinations and electrocardiograms (ECGs).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Safety and tolerability of of perampanel [ Time Frame: Approximately 56 days ]
Safety will be assessed by the monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, weight, physical examinations, electrocardiograms (ECGs).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
Official Title  ICMJE A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
Brief Summary This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Perampanel
    2 mg up to 4 mg
  • Drug: Perampanel
    2 mg up to 6 mg
Study Arms  ICMJE
  • Experimental: Group A
    Experimental
    Intervention: Drug: Perampanel
  • Experimental: Group B
    Days 1-14: Multiple oral dose of 2 mg perampanel (one 2 mg tablet) Days 15-28: Multiple oral dose of 4 mg perampanel (two 2 mg tablets) Days 29-42: Multiple oral dose of 6 mg perampanel (three 2 mg tablets)
    Intervention: Drug: Perampanel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Subjects who meet all of the following criteria will be included in the study:

  1. Korean healthy adult male volunteers
  2. Non-smoking, male subjects aged at least 19 years and no more than 55 years old at the time of informed consent
  3. Body Mass Index (BMI) of greater than 18 and less than or equal to 30 kg/m2 at Screening. Note: BMI (kg/m2) = body weight (kg)/[height (m) x height (m)]
  4. Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners are not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation
  5. Provide written informed consent
  6. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the study:

  1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  2. Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing; e.g., psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
  3. Any history of gastrointestinal surgery that may affect PK profiles of perampanel, e.g., hepatectomy, nephrotomy, digestive organ resection at Screening and Baseline
  4. Evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations. Subjects whose liver enzyme values are outside of the acceptable normal limits will be excluded
  5. A prolonged QT/QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening or Baseline
  6. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening
  7. Any lifetime suicidal behavior
  8. Known history of clinically significant drug allergy at Screening and Baseline
  9. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening and Baseline
  10. Known to be human immunodeficiency virus (HIV) positive at Screening
  11. Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening
  12. History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline
  13. Intake of caffeinated beverages or food within 72 hours prior to dosing
  14. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect CYP (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard], and charbroiled meats) within 1 week prior to dosing
  15. Intake of herbal preparations containing St. John's Wort within 4 weeks prior to dosing
  16. Use of prescription drugs within 4 weeks prior to dosing
  17. Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
  18. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5x the half-life, whichever is longer preceding informed consent
  19. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within one week of dosing
  20. Engagement in strenuous exercise within 2 weeks prior to check-in (e.g., marathon runners, weight lifters, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020486
Other Study ID Numbers  ICMJE E2007-K082-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor  ICMJE Eisai Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP