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The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK618334 low Dose | Experimental | GSK618334 Low Dose |
|
| GSK618334 Medium Dose | Experimental | GSK618334 medium dose arm |
|
| GSK618334 High Dose | Experimental | GSK618334 High Dose Arm |
|
| GSK618334 Placebo | Experimental | Placebo for all 3 dose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK618334 Low Dose | Drug | GSK618334 low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels. | First dose to follow-up | |
| To assess blood concentrations of GSK618334 after repeated oral doses. | First dose to 72 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of food on GSK618334 blood concentrations after a single dose. | First dose of the single dose session to 24 hours after dosing of the repeat dose session | |
| The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session. |
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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 | London | NW10 7EW | United Kingdom |
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| Label | URL |
|---|---|
| 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 |
| Results for study 108414 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 108414 | Statistical Analysis Plan | 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 |
|---|---|
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| GSK618334 PET subjects |
| Drug |
PET subjects |
|
| GSK618334 Medium Dose | Drug | Medium Dose |
|
| GSK618334 High Dose | Drug | GSK618334 High Dose |
|
| First dose to 24 hours after last dose |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108414 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108414 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108414 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108414 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108414 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001519 |
| Behavior |