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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01531920
Enrollment
59
Registered
2012-02-13
Start date
2010-05-31
Completion date
2011-04-30
Last updated
2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System

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

DRUGalcohol + placebo

Part A alcohol + placebo

DRUGalcohol + perampanel

Part A: alcohol + perampanel

DRUGperampanel + alcohol

Part B: perampanel + alcohol

DRUGplacebo + alcohol

Part B: placebo + alcohol

Sponsors

Eisai Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

MeasureTime frame
Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alonebaseline to Part A Day 1
Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alonebaseline to Part B Day 62
Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alonebaseline to Part B Day 62
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alonePart B Day 34

Secondary

MeasureTime frame
Part A: Incidence of AEs when perampanel is administered in combination with alcoholbaseline to Part A Day 29
Part B: Incidence of AEs when perampanel is administered in combination with alcoholbaseline to Part B Day 62

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026