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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-08

Study Completion Date

2009-06-11

Brief Summary

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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.

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Detailed Description

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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 GSK618334 will be determined using 11C-PHNO as a PET ligand labeling dopamine receptor. The PK/PD relationship between plasma concentrations of GSK618334 and D3 RO will be described. Potential relationships between D3 RO and functional magnetic resonance imaging (fMRI) endpoints will be assessed as an exploratory aim.

Conditions

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Substance Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label

D3 receptor antagonist

Group Type EXPERIMENTAL

GSK618334

Intervention Type DRUG

D3 receptor antagonist

Interventions

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GSK618334

D3 receptor antagonist

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Harrow, Middlesex, United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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