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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
Part A alcohol + placebo
Part A: alcohol + perampanel
Part B: perampanel + alcohol
Unnamed facility
Guildford, United Kingdom
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone
Time frame: 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
Time frame: baseline to Part B Day 62
Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone
Time frame: baseline to Part B Day 62
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
Time frame: Part B Day 34
Part A: Incidence of AEs when perampanel is administered in combination with alcohol
Time frame: baseline to Part A Day 29
Part B: Incidence of AEs when perampanel is administered in combination with alcohol
Time frame: baseline to Part B Day 62
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Part B: placebo + alcohol