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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 )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Nervous System Drug: alcohol + placebo Drug: alcohol + perampanel Drug: perampanel + alcohol Drug: placebo + alcohol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
alcohol + placebo
Part A alcohol + placebo
 Drug: alcohol + placebo
Part A alcohol + placebo
alcohol + perampanel
Part A : alcohol + perampanel
 Drug: alcohol + perampanel
Part A: alcohol + perampanel
perampanel + alcohol
Part B: perampanel + alcohol
 Drug: perampanel + alcohol
Part B: perampanel + alcohol
placebo + alcohol
Part B: placebo + alcohol
 Drug: placebo + alcohol
Part B: placebo + alcohol


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone [ Time Frame: baseline to Part B Day 62 ]
  4. Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone [ Time Frame: Part B Day 34 ]

Secondary Outcome Measures :
  1. Part A: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part A Day 29 ]
  2. Part B: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part B Day 62 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT01531920


Locations
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United Kingdom
Guildford, United Kingdom
Sponsors and Collaborators
Eisai Limited
Investigators
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Principal Investigator: Daryl Bendel Surrey Clinical Research Centre
More Information
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Responsible Party: Eisai Limited
ClinicalTrials.gov Identifier: NCT01531920    
Other Study ID Numbers: E2007-E044-030
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs