An Imaging Study to Investigate the Distribution of GW842... | NCT00511524

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

NCT00511524

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 7, 2017Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Pain, Inflammatory

Interventions

GW842166X
[carbonyl-^11C]GW842166

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2007Actual

Primary Completion Date

Jul 4, 2007Actual

Completion Date

Jul 4, 2007Actual

First Submitted Date

Aug 2, 2007

First Submission Date that Met QC Criteria

Aug 2, 2007

First Posted Date

Aug 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2017

Last Update Posted Date

Aug 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate at which the drug crosses from plasma to brain (ki)using images from the scan		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Safety of drug		after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Uppsala		SE-753 23	Sweden

References Module

Citations

Not provided

ID	Term
D010146	Pain
D007249	Inflammation
D000377	Agnosia

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes