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| Name | Class |
|---|---|
| University of Cambridge | OTHER |
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The aim of the study is to assess the safety and tolerability of GSK1521498 in combination with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.
The study is to test a new drug which may be used for treating alcohol addiction. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much alcohol we drink and the pleasure we get from drinking alcohol. We believe that GSK1521498 might be effective in the treatment of alcohol addiction because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from drinking alcohol. As alcohol can effect the way that a drug is metabolised in the body, The investigators need to determine that it is safe to take GSK1521498 in combination with alcohol. and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1521498 & alcohol | Experimental | GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice) |
|
| GSK1521498 & orange juice | Experimental | GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour |
|
| Placebo & alcohol | Experimental | Placebo and alcohol (0.5g/kg ethanol mixed with orange juice) |
|
| Placebo & orange juice | Placebo Comparator | Placebo and orange juice approximately matching alcoholic beverage for volume and colour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1521498 | Drug | GSK1521498 20 mg administered with alcohol to determine PK/PD interactions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic interaction | AUC and Cmax of GSK1521498 and alcohol | GSK1521498 PK sampling; pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48 and 72 hr post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments | 3 Months | |
| Neurological assessments including Purdue Pegboard test | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| Results for study 115256 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115256 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568078 | N-((3,5-difluoro-3'-(1H-1,2,4-triazol-3-yl)-4-biphenylyl)methyl)-2,3-dihydro-1H-inden-2-amine |
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| Placebo | Other | Placebo |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115256 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |