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

NCT ID: NCT00511524

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-26

Study Completion Date

2007-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Inflammatory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GW842166X

Intervention Type 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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

[carbonyl-^11C]GW842166

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CBA103679

Identifier Type: -

Identifier Source: org_study_id

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