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Completed

NCT Number: NCT01181908

Alcohol Interaction Study

The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Leiden, 2333 CL, Netherlands

About this study

The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female
  • Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
  • Willing to use appropriate contraception methods

Exclusion criteria

  • Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
  • Any serious medical disorder or condition
  • Any history of an endocrine disorder.
  • Any clinically significant laboratory abnormality.
  • History of psychiatric illness.
  • Any history of suicidal attempts or behavior.
  • Positive urine drug screen or positive blood alcohol
  • Pregnant, nursing or potential to have a child
  • Past history of alcohol dependence or abuse.
  • History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
  • smokers

Treatment and study plan

single dose

Drug

Subjects will receive a single dose of GSK1144814 or placebo.

Primary outcomes

  1. pharmacodynamic measures for various psychomotor/cognition function and subjective effects

    Time frame: pre and post study drug administration

Secondary outcomes

  1. alcohol level

    Time frame: during and post alcohol administration

  2. blood level of GSK1144814

    Time frame: pre and post study drug administration

  3. safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales

    Time frame: throughout the study pre- and post dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2010
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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