Alcohol Interaction Study

Phase 1CompletedNCT01181908

GlaxoSmithKline21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Alcoholism

Interventions

single doseDRUG

Subjects will receive a single dose of GSK1144814 or placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Leiden, Netherlands

Outcomes

Primary Outcomes

pharmacodynamic measures for various psychomotor/cognition function and subjective effects

Time frame: pre and post study drug administration

Secondary Outcomes

alcohol level

Time frame: during and post alcohol administration

blood level of GSK1144814

Time frame: pre and post study drug administration

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

Data from ClinicalTrials.gov

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