Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
- Registration Number
- NCT00945503
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A PET study using \[11c\]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GSK1018921 GSK1018921 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.
- Primary Outcome Measures
Name Time Method PET occupancy with GSK1018921 10 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Barcelona, Spain