Status:
COMPLETED
An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand
Lead Sponsor:
GlaxoSmithKline
Conditions:
Substance Dependence
Eligibility:
MALE
30-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the D3 receptors of the brain after dosing of...
Detailed Description
This imaging study will be an open label, non-randomised PET receptor occupancy study using healthy male volunteers. The time course and degree of D3 receptor occupancy (RO) after single doses of GSK6...
Eligibility Criteria
Inclusion
- healthy, male subjects aged between 30 and 55 old inclusive.
- normal body weight.
- normal ECG and vital signs.
- agree to use acceptable contraceptive methods required.
- capable of giving written informed consent.
Exclusion
- smoker or uses other nicotine-containing products.
- certain medical conditions including heart disease, neurological disease, gastrointestinal disease, kidney or liver dysfunction - abnormal laboratory tests.
- certain psychiatric conditions and use of certain psychoactive drugs .
- positive blood alcohol or urine drug test.
- alcohol intake over 14 drinks per week.
- participation in another drug trial within 30 days or a study involving significant radiation exposure.
- donation of more than 450 mL blood within the 56 days.
- family history of cancer (one or more first-degree relative diagnosed before the age of 55 years old).
- having cardiac pacemaker or other electronic device.
- suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera.
Key Trial Info
Start Date :
December 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00814957
Start Date
December 8 2008
End Date
June 11 2009
Last Update
July 7 2017
Active Locations (1)
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1
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ