Status:
COMPLETED
Alcohol Interaction Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 receiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01181908
Start Date
November 11 2009
End Date
December 30 2009
Last Update
June 27 2017
Active Locations (1)
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1
GSK Investigational Site
Leiden, Netherlands, 2333 CL