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

NCT00814957 | Completed Phase 1

• 1 other identifier: 110269
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Dependence

Keywords

positron emission tomography; addiction

Outcome Measures

Primary Outcomes (3)

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

  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.

  up to 48 hours

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

  up to 48 hours

Secondary Outcomes (2)

• 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

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

  up to 48 hours

Study Arms (1)

Open-label

EXPERIMENTAL

D3 receptor antagonist

Drug: GSK618334

Interventions

GSK618334 DRUG

D3 receptor antagonist

Open-label

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: December 8, 2008
• Primary Completion: June 11, 2009
• Study Completion: June 11, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)