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

This study has been completed.

First Received: February 13, 2007 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00435695

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK163090	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	An Open Label, Non-Randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090 [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Vitals signs ECGs Clinical Laboratory test results [ Time Frame: throughout the study ]

Enrollment:	13
Study Start Date:	November 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435695

Locations

Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5T 1R8

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	HTP103265
Study First Received:	February 13, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00435695 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

PET scan
healthy males

Study placed in the following topic categories:

Healthy
Serotonin

ClinicalTrials.gov processed this record on May 07, 2009