Alcohol Interaction Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01181908 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : June 27, 2017
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Condition or disease | Intervention/treatment | Phase |
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Alcoholism | Drug: single dose | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects. |
Actual Study Start Date : | November 11, 2009 |
Actual Primary Completion Date : | December 30, 2009 |
Actual Study Completion Date : | December 30, 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: GSK1144814
Subjects will receive either GSK1144814 or placebo at each treatment arm.
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Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo. |
Placebo Comparator: placebo
Subjects will receive either GSK1144814 or placebo at each treatment arm.
|
Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo. |
- pharmacodynamic measures for various psychomotor/cognition function and subjective effects [ Time Frame: pre and post study drug administration ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181908
Netherlands | |
GSK Investigational Site | |
Leiden, Netherlands, 2333 CL |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01181908 |
Other Study ID Numbers: |
113476 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | June 27, 2017 |
Last Verified: | June 2017 |
alcohol drug interaction pharmacodynamic |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |