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GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 14 days dosing |
|
| Cohort 2 | Experimental | Single dose followed by 14 days repeat dosing |
|
| Cohort 3 | Experimental | Up to 28 days repeat dosing with drug interaction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1043702 | Drug | Oral dose in liquid or tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations. | Up to 28 days | |
| GSK1034702 PK parameters: Cmax; tmax; AUC(0-t) | Up to 28 days | |
| Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t). | Day -2, 1 and 14 | |
| Effects on Cognitive tests. | Up to day 28 | |
| Effects on salivary secretion | up to 28 days |
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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 110792 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110792 | 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 |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Dextromethorphan | Drug | 30mg Oral dose |
|
| Placebo | Drug | To match GSK1034702 |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110792 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |