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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol

Conditions
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Central Nervous System

Intervention / Treatment
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* Drug: alcohol + placebo
* Drug: alcohol + perampanel
* Drug: perampanel + alcohol
* Drug: placebo + alcohol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: alcohol + placebo<br>Part A alcohol + placebo | Drug: alcohol + placebo<br>* Part A alcohol + placebo<br>|
| Other: alcohol + perampanel<br>Part A : alcohol + perampanel | Drug: alcohol + perampanel<br>* Part A: alcohol + perampanel<br>|
| Other: perampanel + alcohol<br>Part B: perampanel + alcohol | Drug: perampanel + alcohol<br>* Part B: perampanel + alcohol<br>|
| Other: placebo + alcohol<br>Part B: placebo + alcohol | Drug: placebo + alcohol<br>* Part B: placebo + alcohol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone |  | 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 |  | baseline to Part B Day 62 | 
| Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone |  | baseline to Part B Day 62 | 
| Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone |  | Part B Day 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Incidence of AEs when perampanel is administered in combination with alcohol |  | baseline to Part A Day 29 | 
| Part B: Incidence of AEs when perampanel is administered in combination with alcohol |  | baseline to Part B Day 62 |