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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014