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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511524
First Posted: August 6, 2007
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 2, 2007
August 6, 2007
August 7, 2017
June 26, 2007
July 4, 2007   (Final data collection date for primary outcome measure)
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain, Inflammatory
  • Drug: GW842166X
    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.
Experimental: Subjects receiving GW842166
Subjects will receive single oral dose of 400 milligram (mg) un-labeled GW842166X. After 2-5 hours subjects will receive [carbonyl-^11C]GW842166.
Interventions:
  • Drug: GW842166X
  • Drug: [carbonyl-^11C]GW842166
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
July 4, 2007
July 4, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
50 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00511524
CBA103679
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

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