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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Limited
• Treatments: Ethanol

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