Status:

COMPLETED

EtOH Interaction Study

Lead Sponsor:

GlaxoSmithKline

Conditions:

Substance Dependence

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

This study will investigate the possible effects of alcohol in combination with GSK598809 on the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years of age. Durin...

Detailed Description

This is a blinded, randomised, placebo-controlled, double-dummy, four-period crossover study to investigate the psychomotor and cognitive effects of GSK598809 alone and in combination with ethanol in ...

Eligibility Criteria

Inclusion

  • Generally healthy.
  • Occasional non-daily smokers.
  • Willing to use appropriate contraception method.
  • Weight more than 50 kg.
  • BMI within the range 18 - 30 kg/m2.

Exclusion

  • Pregnant or breast feeding female.
  • Daily smoker.
  • Asthma or a history of asthma.
  • Abuse of drugs or alcohol.
  • Psychiatric illness.

Key Trial Info

Start Date :

September 29 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 3 2008

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00887367

Start Date

September 29 2008

End Date

December 3 2008

Last Update

July 18 2017

Active Locations (1)

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1

GSK Investigational Site

Leiden, Netherlands, 2333 CL