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The purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the D3 receptors of the brain after dosing of a new compound GSK618334.
This imaging study will be an open label, non-randomised PET receptor occupancy study using healthy male volunteers. The time course and degree of D3 receptor occupancy (RO) after single doses of GSK618334 will be determined using 11C-PHNO as a PET ligand labeling dopamine receptor. The PK/PD relationship between plasma concentrations of GSK618334 and D3 RO will be described. Potential relationships between D3 RO and functional magnetic resonance imaging (fMRI) endpoints will be assessed as an exploratory aim.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | D3 receptor antagonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK618334 | Drug | D3 receptor antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binding of PHNO, PET ligand, in each region of interest at each scan. | up to 48 hours | |
| Percentage of PHNO, PET ligand, occupancy in each region of interest after a single oral dose of GSK618334 for each individual. | up to 48 hours | |
| Time course of GSK618334 concentration in blood following a single oral dose. | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and other safety assessments such as clinically relevant changes in electrocardiography (ECG); vital signs (blood pressure, heart rate); laboratory safety data and physical examination. | screening to follow-up | |
| Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax. |
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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 | Harrow | Middlesex | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 110269 can be found on the GSK Clinical Study Register. | View source |
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110269 | Individual Participant Data Set | 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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| up to 48 hours |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110269 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001519 |
| Behavior |