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

Primary Purpose

Substance Dependence

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK618334

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring positron emission tomography, addiction

Eligibility Criteria

30 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label

Arm Description

D3 receptor antagonist

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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.

Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax.

Full Information

NCT ID

NCT00814957

First Posted

December 23, 2008

Last Updated

July 5, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00814957

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 8, 2008 (Actual)

Primary Completion Date

June 11, 2009 (Actual)

Study Completion Date

June 11, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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 a new compound GSK618334.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Dependence

Keywords

positron emission tomography, addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-label

Arm Type

Experimental

Arm Description

D3 receptor antagonist

Intervention Type

Drug

Intervention Name(s)

GSK618334

Intervention Description

D3 receptor antagonist

Primary Outcome Measure Information:

Title

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

Time Frame

up to 48 hours

Title

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

Time Frame

up to 48 hours

Title

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

Time Frame

up to 48 hours

Secondary Outcome Measure Information:

Title

Time Frame

screening to follow-up

Title

Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax.

Time Frame

up to 48 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110269

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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