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

Eisai

Status and phase: Completed; Phase 1

Conditions: Central Nervous System

Treatments: Drug: perampanel + alcohol; Drug: placebo + alcohol; Drug: alcohol + placebo; Drug: alcohol + perampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01531920

E2007-E044-030

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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59 participants in 4 patient groups

alcohol + placebo

Other group

Description:

Part A alcohol + placebo

Treatment:

Drug: alcohol + placebo

alcohol + perampanel

Other group

Description:

Part A : alcohol + perampanel

Treatment:

Drug: alcohol + perampanel

perampanel + alcohol

Other group

Description:

Part B: perampanel + alcohol

Treatment:

Drug: perampanel + alcohol

placebo + alcohol

Other group

Description:

Part B: placebo + alcohol

Treatment:

Drug: placebo + alcohol