Central Nervous System
Conditions
Brief 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.
Interventions
Part A alcohol + placebo
Part A: alcohol + perampanel
Part B: perampanel + alcohol
Part B: placebo + alcohol
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United Kingdom