An Imaging Study to Investigate the Distribution of GW842166X in the Brain.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00511524
First received: August 2, 2007
Last updated: March 15, 2012
Last verified: February 2011

August 2, 2007
March 15, 2012
June 2007
Not Provided
Rate at which the drug crosses from plasma to brain (ki)using images from the scan [ Time Frame: throughout the study ]
Same as current
Complete list of historical versions of study NCT00511524 on ClinicalTrials.gov Archive Site
Safety of drug [ Time Frame: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up. ]
Same as current
Not Provided
Not Provided
 
An Imaging Study to Investigate the Distribution of GW842166X in the Brain.
An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Analgesia
  • Inflammation
  • Pain, Inflammatory
Drug: GW842166X
Other Name: GW842166X
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Not Provided
Not Provided

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
Male
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00511524
CBA103679
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP