Alcohol Interaction Study

Phase 1

Completed

• Conditions: Alcoholism
• Interventions: Drug: single dose

• Registration Number: NCT01181908
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2009-11-11
• Study First Submitted: 2009-12-17
• Primary Completion: 2009-12-30
• Study Completion: 2009-12-30
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	single dose	Subjects will receive either GSK1144814 or placebo at each treatment arm.
GSK1144814	single dose	Subjects will receive either GSK1144814 or placebo at each treatment arm.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
blood level of GSK1144814	pre and post study drug administration
alcohol level	during and post alcohol 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

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Leiden, Netherlands