CompletedPhase 1

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

United Kingdom12 participantsStarted 2008-12-08

Plain-language 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.

Who can participate

Age range

30 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Binding of PHNO, PET ligand, in each region of interest at each scan.

Timeframe: up to 48 hours

Percentage of PHNO, PET ligand, occupancy in each region of interest after a single oral dose of GSK618334 for each individual.

Timeframe: up to 48 hours

Time course of GSK618334 concentration in blood following a single oral dose.

Timeframe: up to 48 hours

Trial details

NCT IDNCT00814957

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06-11

View on ClinicalTrials.gov More Substance Dependence trials

Who can participate

Age range

30 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Binding of PHNO, PET ligand, in each region of interest at each scan.

Timeframe: up to 48 hours

Percentage of PHNO, PET ligand, occupancy in each region of interest after a single oral dose of GSK618334 for each individual.

Timeframe: up to 48 hours

Time course of GSK618334 concentration in blood following a single oral dose.

Timeframe: up to 48 hours