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Home > Protocol Summaries: Compounds > GSK618334 > Protocol Summary for 110269

Protocol Summary for 110269

Protocol Summary
Protocol Id: 110269
Secondary Ids:
  • N/A
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.
Phase: phase 1
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare products Regulatory Agency
Collaborators:
  • N/A
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.
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: December 2008
Study Completion Date: June 2009
Study Completion Date Type: Actual
Primary Completion Date: June 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Pharmacodynamics Study
Primary Outcomes:
  • Binding of PHNO, PET ligand, in each region of interest at each scan. no 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. no up to 48 hours
  • Time course of GSK618334 concentration in blood following a single oral dose. no up to 48 hours
Secondary Outcomes:
  • 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. yes screening to follow-up
  • Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax. no up to 48 hours
Conditions:
  • Substance Dependence
Keywords:
  • addiction
  • positron emission tomography
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Male
Minimum Age: 30 Year
Maximum Age: 55 Year
Enrollment: 12
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information