A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
Phase 1
Completed
- Conditions
- Central Nervous System
- Interventions
- Registration Number
- NCT01531920
- Lead Sponsor
- Eisai Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description alcohol + placebo alcohol + placebo Part A alcohol + placebo alcohol + perampanel alcohol + perampanel Part A : alcohol + perampanel perampanel + alcohol perampanel + alcohol Part B: perampanel + alcohol placebo + alcohol placebo + alcohol Part B: placebo + alcohol
- Primary Outcome Measures
Name Time Method Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone Part B Day 34 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
- Secondary Outcome Measures
Name Time Method 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