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

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

Tracking Information

• First Submitted Date: February 9, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: February 13, 2012
• Study Start Date: May 2010
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Central Nervous System

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2012): 59
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01531920
• Other Study ID Numbers: E2007-E044-030
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eisai Inc. ( Eisai Limited )
• Study Sponsor: Eisai Limited
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daryl Bendel; Surrey Clinical Research Centre

• PRS Account: Eisai Inc.
• Verification Date: January 2012