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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00814957
First received: December 23, 2008
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Addiction
Substance Dependence
Drug: GSK618334
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Binding of PHNO, PET ligand, in each region of interest at each scan. [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time course of GSK618334 concentration in blood following a single oral dose. [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

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. [ Time Frame: screening to follow-up ] [ Designated as safety issue: Yes ]
  • Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax. [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label
D3 receptor antagonist
Drug: GSK618334
D3 receptor antagonist

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814957

Locations
United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00814957     History of Changes
Other Study ID Numbers: 110269
Study First Received: December 23, 2008
Last Updated: July 9, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
addiction
positron emission tomography

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014