An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.
GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy). This study will use the technique of positron emission tomography (PET) as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and subsequently bound to receptors, after receiving an oral dose of the drug. It will also look at the rate the drug dissociates from the receptors in the brain. Results from the study will provide information on doses of the drug to be given in further studies.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PET Study Using [11C] GSK189254 to Establish the Dose, Plasma Concentration and Brain Receptor Occupancy Relationship of GSK239512, a Histamine H3 Antagonist, in Healthy Subjects|
- Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET images at 4 hours and 24 hours post dose
- Safety of drug and concentration of GSK239512 in the blood at various timepoints. Using vital signs and ECG, clinical laboratory assessments and PK sampling.
|Study Start Date:||March 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474513
|GSK Investigational Site|
|Toronto, Ontario, Canada, M5T 1R8|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|