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

NCT01531920 | Completed Phase 1

• 1 other identifier: E2007-E044-030
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (4)

alcohol + placebo

OTHER

Part A alcohol + placebo

Drug: alcohol + placebo

alcohol + perampanel

OTHER

Part A : alcohol + perampanel

Drug: alcohol + perampanel

perampanel + alcohol

OTHER

Part B: perampanel + alcohol

Drug: perampanel + alcohol

placebo + alcohol

OTHER

Part B: placebo + alcohol

Drug: placebo + alcohol

Interventions

alcohol + placebo DRUG

Part A alcohol + placebo

alcohol + placebo

alcohol + perampanel DRUG

Part A: alcohol + perampanel

alcohol + perampanel

perampanel + alcohol DRUG

Part B: perampanel + alcohol

perampanel + alcohol

placebo + alcohol DRUG

Part B: placebo + alcohol

placebo + alcohol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Unknown Facility

Guildford, United Kingdom

Location

MeSH Terms

Interventions

Ethanol; perampanel

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Daryl Bendel

  Surrey Clinical Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 13, 2012
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 13, 2012

Record last verified: 2012-01

Locations

GB (1)