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This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.
This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK356278 | Experimental | Investigational drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK356278 | Drug | Investigational Medicinal Product |
| |
| Rolipram |
| Measure | Description | Time Frame |
|---|---|---|
| Positron Gamma-ray emmision & voxel counts | Brain regions of interest and associated radionuclitide-activity | 60 minutes |
| systemic plasma concentration | serial sampling: GSK356278 concentration expressed as mass per unit of volume | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure - mm/Hg | Standard clinical pharmacology safety monitoring of vital signs | 24 hours |
| ECG - 12-Lead & Telemetry | Standard clinical pharmacology safety monitoring |
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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 | |||
| GSK Investigational Site |
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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 116038 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116038 | Annotated Case Report Form | 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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| Drug |
Challenge Agent |
|
| 24 & 72 hours |
| Heart rate - bpm | Standard clinical pharmacology safety monitoring of vital signs | 72 hours |
| London |
| W12 ONN |
| United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116038 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000590928 | 5-(5-((2,4-dimethylthiazol-5-yl)methyl)-1,3,4-oxadiazol-2-yl)-1-ethyl-N-(tetrahydro-2H-pyran-4-yl)-1H-pyrazolo(3,4-b)pyridin-4-amine |
| D020889 | Rolipram |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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