Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Healthy Subjects

Depressive Disorder and Anxiety Disorders

Eligibility:

MALE

18-45 years

Phase:

PHASE1

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT00435695

Start Date

November 1 2006

End Date

December 1 2007

Last Update

June 4 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

GSK Investigational Site

Toronto, Ontario, Canada, M5T 1R8