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

July 23, 2009
July 30, 2009
May 2008
December 2008   (final data collection date for primary outcome measure)
PET occupancy with GSK1018921 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00945503 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
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.

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: GSK1018921
GSK1018921 is a GT1 recepor antagonist
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.
Intervention: Drug: GSK1018921
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2009
December 2008   (final data collection date for primary outcome measure)
  • 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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00945503
109731
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP