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

Phase 1

Completed

• Conditions: Healthy Subjects; Depressive Disorder and Anxiety Disorders
• Interventions: Drug: GSK163090

• Registration Number: NCT00435695
• Lead Sponsor: GlaxoSmithKline

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 available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-13
• Study First Posted: 2007-02-15
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GSK163090	GSK163090	one infusion only

Primary Outcome Measures

Name	Time	Method
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090	throughout the study

Secondary Outcome Measures

Name	Time	Method
Vitals signs ECGs Clinical Laboratory test results	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Toronto, Ontario, Canada