Study Of Safety, Blood Levels, And Brain Receptor Occupan... | NCT00435695

Studies
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males

NCT00435695

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 4, 2012Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Healthy Subjects
Depressive Disorder and Anxiety Disorders

Interventions

GSK163090

Countries

Canada

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

May 2011

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

Nov 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Feb 13, 2007

First Submission Date that Met QC Criteria

Feb 13, 2007

First Posted Date

Feb 15, 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

May 31, 2012

Last Update Posted Date

Jun 4, 2012Estimated

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

The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called [11C]-WAY100635.

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

13Actual

Label	Type	Description	Intervention Names
GSK163090	Active Comparator	one infusion only	Drug: GSK163090

Name	Type	Description	Arm Group Labels	Other Names
GSK163090	Drug		GSK163090

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Vitals signs ECGs Clinical Laboratory test results		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects, aged 18-45 years Body weight > 50 kg
Non-Smoker
Normal ECG, heart rate and blood pressure

Exclusion Criteria:

History of any cardiac disease
History of regular alcohol consumption averaging >14 drinks/week
Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
Positive for Hepatitis B and C, and HIV.
History of drug abuse.
Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
Suffers from claustrophobia
History or presence of neurological or psychiatric conditions
Presence of a cardiac pacemaker or other implanted electronic device or metal implants

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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		Toronto	Ontario	M5T 1R8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C587791	1-(3-(2-(4-(2-methyl-5-quinolinyl)-1-piperazinyl)ethyl)phenyl)-2-imidazolidinone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided