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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
  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
Pain, Inflammatory Drug: GW842166X Drug: [carbonyl-^11C]GW842166 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date: June 26, 2007
Study Completion Date: July 4, 2007
Primary Completion Date: July 4, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511524


Locations
Sweden
GSK Investigational Site
Uppsala, Sweden, SE-753 23
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00511524     History of Changes
Other Study ID Numbers: CBA103679
First Submitted: August 2, 2007
First Posted: August 6, 2007
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
brain,
inflammation,
CB2,
PET
analgesia,