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

Central Nervous System Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531920
• Other study ID #: E2007-E044-030
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2012
• Last updated: February 10, 2012
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2012
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Medicines Agency: England
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Nervous System

Intervention

Drug:
• alcohol + placebo
Part A alcohol + placebo
• alcohol + perampanel
Part A: alcohol + perampanel
• perampanel + alcohol
Part B: perampanel + alcohol
• placebo + alcohol
Part B: placebo + alcohol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Part B:Changes in Cognitive Function due to perampanel and alcohol combined and perampanel alone		baseline to Part B Day 62	No
Primary	Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone		Part B Day 34	No
Secondary	Part A: Incidence of AEs when perampanel is administered in combination with alcohol		baseline to Part A Day 29	Yes
Secondary	Part B: Incidence of AEs when perampanel is administered in combination with alcohol		baseline to Part B Day 62	Yes