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

NCT00511524 | Completed Phase 1

• 1 other identifier: CBA103679
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Inflammatory

Keywords

brain,; inflammation,; CB2,; PET; analgesia,

Outcome Measures

Primary Outcomes (1)

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

  throughout the study

Secondary Outcomes (1)

• Safety of drug

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

Study Arms (1)

Subjects receiving GW842166

EXPERIMENTAL

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; Drug: [carbonyl-^11C]GW842166

Interventions

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.

Subjects receiving GW842166

[carbonyl-^11C]GW842166 DRUG

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

Subjects receiving GW842166

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Uppsala, SE-753 23, Sweden

Location

Related Links

• Results for study CBA103679 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pain; Inflammation; Agnosia

Interventions

2-((2,4-dichlorphenyl)amino)-N-((tetrahydro-2H-pyran-4-yl)methyl)-4-(trifluoromethyl)-5-pyrimidinecarboxamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 6, 2007
• Study Start: June 26, 2007
• Primary Completion: July 4, 2007
• Study Completion: July 4, 2007
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

SE (1)