Alcohol Interaction Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181908

Enrollment

Registered

2010-08-13

Start date

2009-11-11

Completion date

2009-12-30

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Keywords

alcohol, drug interaction, pharmacodynamic

Brief summary

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

Detailed description

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.

Interventions

DRUGsingle dose

Subjects will receive a single dose of GSK1144814 or placebo.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
pharmacodynamic measures for various psychomotor/cognition function and subjective effects	pre and post study drug administration

Secondary

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026