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The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1144814 | Experimental | Subjects will receive either GSK1144814 or placebo at each treatment arm. |
|
| placebo | Placebo Comparator | Subjects will receive either GSK1144814 or placebo at each treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single dose | Drug | Subjects will receive a single dose of GSK1144814 or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacodynamic measures for various psychomotor/cognition function and subjective effects | pre and post study drug administration |
| Measure | Description | 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 |
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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 | Leiden | 2333 CL | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23067311 | Background | te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JM. Pharmacokinetics and central nervous system effects of the novel dual NK1 /NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2013 May;75(5):1328-39. doi: 10.1111/bcp.12004. |
| Label | URL |
|---|---|
| Results for study 113476 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| throughout the study pre- and post dose |