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

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 Overview

• Status: Completed
• Conditions: Central Nervous System
• Intervention / Treatment: Drug: alcohol + placebo; Drug: alcohol + perampanel; Drug: perampanel + alcohol; Drug: placebo + alcohol

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Guildford, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: alcohol + placebo; Part A alcohol + placebo	Drug: alcohol + placebo; Part A alcohol + placebo
Other: alcohol + perampanel; Part A : alcohol + perampanel	Drug: alcohol + perampanel; Part A: alcohol + perampanel
Other: perampanel + alcohol; Part B: perampanel + alcohol	Drug: perampanel + alcohol; Part B: perampanel + alcohol
Other: placebo + alcohol; Part B: placebo + alcohol	Drug: placebo + alcohol; Part B: placebo + alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Part B: Part B: Changes in driving performance (simulated) due to perampanel and alcohol combined and perampanel alone	Part B Day 34

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai Limited
• Investigators: Principal Investigator: Daryl Bendel, Surrey Clinical Research Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2012
• Last Update Submitted That Met QC Criteria: February 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: E2007-E044-030