Pain, Inflammatory
Conditions
Keywords
brain,, inflammation,, CB2,, PET, analgesia,
Brief summary
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.
Interventions
DRUGGW842166X
GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.
DRUG[carbonyl-^11C]GW842166
\[carbonyl-\^11C\]GW842166 will b available as Intravenous solution.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate at which the drug crosses from plasma to brain (ki)using images from the scan | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Safety of drug | after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up. |
Countries
Sweden
Outcome results
None listed