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

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 Intervention Model: Parallel Assignment Masking: No masking 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:

Genetics Home Reference related topics: schizophrenia

Drug Information available for: Glycine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

PET occupancy with GSK1018921 [ Time Frame: 10 days ]

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 ]


Enrollment:	12
Actual Study Start Date:	May 19, 2008
Study Completion Date:	December 22, 2008
Primary Completion Date:	December 22, 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 (Adult)
Sexes 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

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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

Additional Information:

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