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
  Purpose

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 Intervention Phase
Central Nervous System
Drug: alcohol + placebo
Drug: alcohol + perampanel
Drug: perampanel + alcohol
Drug: placebo + alcohol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531920

Locations
United Kingdom
Guildford, United Kingdom
Sponsors and Collaborators
Eisai Limited
Investigators
Principal Investigator: Daryl Bendel Surrey Clinical Research Centre
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01531920     History of Changes
Other Study ID Numbers: E2007-E044-030
Study First Received: February 9, 2012
Last Updated: February 10, 2012
Health Authority: European Medicines Agency: England

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014