An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand

• Status: Completed
• Trial end date: 2009-06-11
• Target enrollment: 0
• Participant gender: Male

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 a new compound GSK618334.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Naxagolide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.