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

Substance Dependence Clinical Trial

Official title:

An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain Dopamine D3 Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK618334, Using 11C-PHNO as PET Ligand.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814957
• Other study ID #: 110269
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2008
• Last updated: July 5, 2017
• Start date: December 8, 2008
• Est. completion date: June 11, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 11, 2009
• Est. primary completion date: June 11, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• GSK618334
D3 receptor antagonist

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binding of PHNO, PET ligand, in each region of interest at each scan.		up to 48 hours
Primary	Percentage of PHNO, PET ligand, occupancy in each region of interest after a single oral dose of GSK618334 for each individual.		up to 48 hours
Primary	Time course of GSK618334 concentration in blood following a single oral dose.		up to 48 hours
Secondary	Adverse events and other safety assessments such as clinically relevant changes in electrocardiography (ECG); vital signs (blood pressure, heart rate); laboratory safety data and physical examination.		screening to follow-up
Secondary	Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax.		up to 48 hours

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 110269 can be found on the GSK Clinical Study Register.