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A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1018921 | Experimental | All subjects will received a dose of GSK1018921 and will peforme three PET scans using the ligand [11C]GSK931145, but in order to obtain adequate sampling of the exposure-time-occupancy curves, a range of doses will be evaluated, and the timing of the post-dose scans will differ between subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1018921 | Drug | GSK1018921 is a GT1 recepor antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| PET occupancy with GSK1018921 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests. | 10 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 | Barcelona | Spain |
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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 109731 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109731 | 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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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C562323 | GSK 1018921 |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109731 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |