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

NCT01531920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2012-02-13

No results posted yet for this study

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

Interventions

DRUG

alcohol + placebo

Part A alcohol + placebo

DRUG

alcohol + perampanel

Part A: alcohol + perampanel

DRUG

perampanel + alcohol

Part B: perampanel + alcohol

DRUG

placebo + alcohol

Part B: placebo + alcohol

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Daryl Bendel · Surrey Clinical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531920 on ClinicalTrials.gov