Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00945503
First received: July 23, 2009
Last updated: July 30, 2009
Last verified: July 2009
  Purpose

A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.


Condition Intervention Phase
Schizophrenia
Drug: GSK1018921
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Adaptive PET Study in Healthy Volunteers Using [11C]GSK931145 to Establish the Relationship of Glycine Transporter 1 Occupancy by GSK1018921 to Plasma Concentrations Over Time.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PET occupancy with GSK1018921 [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1018921
All subjects will received a dose of GSK1018921 and will peforme three PET scans using the ligand [11C]GSK931145, but in order to obtain adequate sampling of the exposure-time-occupancy curves, a range of doses will be evaluated, and the timing of the post-dose scans will differ between subjects.
Drug: GSK1018921
GSK1018921 is a GT1 recepor antagonist

Detailed Description:

This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion criteria:

    • Healthy male subjects
    • Age: 18-55 years
    • No history of physical, neurological or mental illness
  • Exclusion criteria

    • History of claustrophobia or inability to lie still in the PET camera for at least 2 hours
    • Cardiac pacemakers or metal implants in the body that contraindicate MRI scan.
    • History of regular alcohol consumption (weekly intake >21 units) within the previous six months.
  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: NCT00945503

Locations
Spain
GSK Investigational Site
Barcelona, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00945503     History of Changes
Other Study ID Numbers: 109731
Study First Received: July 23, 2009
Last Updated: July 30, 2009
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by GlaxoSmithKline:
Glycine Tranporter
PET
MRI

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 21, 2014