Clinical trial NCT01531920: A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel
Official title: A Phase 1 Study in Healthy Subjects to Determine the Safety, Tolerability, Psychomotor Function and Cognitive Effects of Perampanel When Administered With Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Nervous System
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Part A: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]), due to perampanel and alcohol combined and perampanel alone
timeFrame: baseline to Part A Day 1
measure: Part B: Changes on Psychomotor Performance (Continuous Tracking Test [CTT]) due to perampanel and alcohol combined and perampanel alone
timeFrame: baseline to Part B Day 62
measure: Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone
timeFrame: baseline to Part B Day 62
measure: Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone
timeFrame: Part B Day 34
Secondary outcomes:
measure: Part A: Incidence of AEs when perampanel is administered in combination with alcohol
timeFrame: baseline to Part A Day 29
measure: Part B: Incidence of AEs when perampanel is administered in combination with alcohol
timeFrame: baseline to Part B Day 62
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
Study officials:
affiliation: Surrey Clinical Research Centre
name: Daryl Bendel
role: PRINCIPAL_INVESTIGATOR
References: