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Completed

NCT Number: NCT00511524

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

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.

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Key information

Conditions

Pain, Inflammatory Agnosia Inflammation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Uppsala, SE-753 23, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW842166X

Drug

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.

[carbonyl-^11C]GW842166

Drug

[carbonyl-^11C]GW842166 will b available as Intravenous solution.

Primary outcomes

  1. Rate at which the drug crosses from plasma to brain (ki)using images from the scan

    Time frame: throughout the study

Secondary outcomes

  1. Safety of drug

    Time frame: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 6, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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