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

Pain, Inflammatory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511524
• Other study ID #: CBA103679
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2007
• Last updated: August 3, 2017
• Start date: June 26, 2007
• Est. completion date: July 4, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 4, 2007
• Est. primary completion date: July 4, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Inflammatory

Intervention

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

Locations

Country	Name	City	State
Sweden	GSK Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate at which the drug crosses from plasma to brain (ki)using images from the scan		throughout the study
Secondary	Safety of drug		after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.

External Links

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