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Protocol Summary for 113549

Protocol Summary
Protocol Id: 113549
Secondary Ids:
Title: A positron emission tomography study in healthy male subjects to examine the test-retest reliability of the D2/3 agonist radiotracer [11C]PHNO
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: Ethics Committee
Collaborators:
Brief Summary: This will be an open label, non-randomised [11C]PHNO PET study using healthy male volunteers. Each volunteer will undergo 4 [11C]PHNO PET scans to allow for further characterisation of this radioligand and examine the effects of [11C]PHNO mass carry-over and displaceable binding in the brain. This study aims to obtain data from 6 evaluable subjects.
Detailed Description: A test-retest (TRT) investigation of [11C]PHNO in human is required to further characterise [11C]PHNO. [11C] PHNO possesses very high affinity for the D3 receptor, and therefore most clinical studies are conducted at D3 occupancies >10%. As [11C]PHNO kinetics in the target brain regions are moderately slow, considerable mass carry over may be present on a 2nd PET scan conducted on the same day. In addition there appears to be a significant displaceable binding component in the cerebellum, which, if not accounted for, will lead to a bias in the quantification of specific [11C]PHNO binding. The aim of this study is therefore to examine the effects of [11C]PHNO mass carry-over and displaceable binding in the cerebellum, on the quantification of [11C]PHNO PET data. This will be an open label, non-randomised [11C]PHNO PET study using healthy volunteers. Each volunteer will undergo 4 [11C]PHNO PET scans: 1st and 2nd scans; TRT on the same day with a minimal gap between [11C]PHNO injections to examine the effects of PHNO mass carry over, 3rd scan >1 week later to determine the “true” TRT variability and a 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors) and will examine the amount of displaceable binding in the cerebellum, a proposed reference tissue for [11C]PHNO. The scan data will be quantified as regional volumes of distribution (VT).
Record Verification Date: September 2011
Status: Completed
Why Study Stopped:
Study Start Date: January 2010
Study Completion Date: July 2010
Study Completion Date Type: Actual
Primary Completion Date: July 2010
Primary Completion Date Type: Actual
Primary Purpose: other
Allocation: N\A
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint):
Primary Outcomes:
  • volume of distribution one year
Secondary Outcomes:
Conditions:
  • Depressive Disorder
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Male
Minimum Age: 22 Year
Maximum Age: 55 Year
Enrollment: 7
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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