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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Depressive Disorder and Anxiety Disorders
• Intervention / Treatment: Drug: GSK163090

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GSK163090; one infusion only	Drug: GSK163090

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 13, 2007
• First Submitted That Met QC Criteria: February 13, 2007
• First Posted (Estimate): February 15, 2007

Study Record Updates

• Last Update Posted (Estimate): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: PET scan; healthy males
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: HTP103265