An Imaging Study to Investigate the Distribution of GW842166X in the Brain.
This study has been completed.
Information provided by (Responsible Party):
First received: August 2, 2007
Last updated: March 15, 2012
Last verified: February 2011
GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects
Primary Outcome Measures:
- Rate at which the drug crosses from plasma to brain (ki)using images from the scan [ Time Frame: throughout the study ]
Secondary Outcome Measures:
- Safety of drug [ Time Frame: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up. ]
| Study Start Date:
Other Name: GW842166X
|Ages Eligible for Study:
||50 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male aged 50 to 80yrs inclusive at the screening visit.
- subjects with negative HIV and hepatitis B and C test results within 3 months of study start.
- A negative Allens test on arm to be used for arterial cannulation.
- Any contraindications to MRI scanning.
- History or presence of hepatic or renal disease.
- Previous involvement in PET or radiological investigations.
- Family history of cancer.
- History of claustrophobia
- Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00511524
|GSK Investigational Site
|Uppsala, Sweden, SE-753 23 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2007
||March 15, 2012
||Sweden: Medical Products Agency
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on March 03, 2015