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
  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
Analgesia
Inflammation
Pain, Inflammatory
Drug: GW842166X
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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
Study Start Date: June 2007
Intervention Details:
    Drug: GW842166X
    Other Name: GW842166X
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00511524     History of Changes
Other Study ID Numbers: CBA103679
Study First Received: August 2, 2007
Last Updated: March 15, 2012
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014