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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01531920
First received: February 9, 2012
Last updated: February 10, 2012
Last verified: January 2012

February 9, 2012
February 10, 2012
May 2010
April 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone [ Time Frame: baseline to Part B Day 62 ] [ Designated as safety issue: No ]
  • Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone [ Time Frame: Part B Day 34 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01531920 on ClinicalTrials.gov Archive Site
  • Part A: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part A Day 29 ] [ Designated as safety issue: Yes ]
  • Part B: Incidence of AEs when perampanel is administered in combination with alcohol [ Time Frame: baseline to Part B Day 62 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Central Nervous System
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01531920
E2007-E044-030
No
Eisai Inc. ( Eisai Limited )
Eisai Limited
Not Provided
Principal Investigator: Daryl Bendel Surrey Clinical Research Centre
Eisai Inc.
January 2012

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