Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Adaptive PET Study in Healthy Volunteers Using [11C]GSK931145 to Establish the Relationship of Glycine Transporter 1 Occupancy by GSK1018921 to Plasma Concentrations Over Time.|
- PET occupancy with GSK1018921 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
GSK1018921 is a GT1 recepor antagonist
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945503
|GSK Investigational Site|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|