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OpenTrials
Completed

NCT Number: NCT00435695

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

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.

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Key information

Conditions

Healthy Subjects Anxiety Disorders Depressive Disorder Depressive Disorder and Anxiety Disorders Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Toronto, Ontario, M5T 1R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK163090

Drug

Primary outcomes

  1. Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090

    Time frame: throughout the study

Secondary outcomes

  1. Vitals signs ECGs Clinical Laboratory test results

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 15, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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