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A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel

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ClinicalTrials.gov Identifier: NCT01531920
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date February 13, 2012
Study Start Date  ICMJE May 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone [ Time Frame: baseline to Part A Day 1 ]
  • Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone [ Time Frame: baseline to Part B Day 62 ]
  • Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone [ Time Frame: baseline to Part B Day 62 ]
  • Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone [ Time Frame: Part B Day 34 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Part A: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part A Day 29 ]
  • Part B: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part B Day 62 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
Official Title  ICMJE A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
Brief Summary A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Central Nervous System
Intervention  ICMJE
  • Drug: alcohol + placebo
    Part A alcohol + placebo
  • Drug: alcohol + perampanel
    Part A: alcohol + perampanel
  • Drug: perampanel + alcohol
    Part B: perampanel + alcohol
  • Drug: placebo + alcohol
    Part B: placebo + alcohol
Study Arms  ICMJE
  • alcohol + placebo
    Part A alcohol + placebo
    Intervention: Drug: alcohol + placebo
  • alcohol + perampanel
    Part A : alcohol + perampanel
    Intervention: Drug: alcohol + perampanel
  • perampanel + alcohol
    Part B: perampanel + alcohol
    Intervention: Drug: perampanel + alcohol
  • placebo + alcohol
    Part B: placebo + alcohol
    Intervention: Drug: placebo + alcohol
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: February 10, 2012)
59
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • Healthy male and female subjects
  • Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
  • Aged 18-55 yrs, inclusive
  • Achieved a Continuous Tracking Test (CTT )score increase of >1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
  • Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)

Exclusion:

  • Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
  • Unable to follow the instructions for the psychometric testing
  • Intolerant to the driving simulator (Part B only)
  • Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
  • Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life [i.e., 5 x t 1/2>2 weeks]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
  • Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)
  • Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531920
Other Study ID Numbers  ICMJE E2007-E044-030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Limited )
Study Sponsor  ICMJE Eisai Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daryl Bendel Surrey Clinical Research Centre
PRS Account Eisai Inc.
Verification Date January 2012

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