Alcohol Interaction Study

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

Detailed Description
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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.

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

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: single dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1144814<br>Subjects will receive either GSK1144814 or placebo at each treatment arm. | Drug: single dose<br>* Subjects will receive a single dose of GSK1144814 or placebo.<br>|
| Placebo Comparator: placebo<br>Subjects will receive either GSK1144814 or placebo at each treatment arm. | Drug: single dose<br>* Subjects will receive a single dose of GSK1144814 or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamic measures for various psychomotor/cognition function and subjective effects |  | pre and post study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alcohol level |  | during and post alcohol administration | 
| blood level of GSK1144814 |  | pre and post study drug administration | 
| safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales |  | throughout the study pre- and post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, drug interaction, pharmacodynamic