An Imaging Study to Investigate the Distribution of GW842166X in the Brain. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00511524

Purpose

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.

Condition	Intervention	Phase
Inflammation Analgesia	Drug: GW842166X	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects

Further study details as provided by GlaxoSmithKline:

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. ]

Enrollment:	6
Study Start Date:	June 2007

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511524

Locations

Sweden
GSK Investigational Site
UPPSALA, Sweden, SE-753 23

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CBA103679
Study First Received:	August 2, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00511524
Health Authority:	Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

inflammation,
CB2,
analgesia,
brain,
PET

Study placed in the following topic categories:

Healthy
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009