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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: GSK1018921	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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.
Actual Study Start Date :	May 19, 2008
Actual Primary Completion Date :	December 22, 2008
Actual Study Completion Date :	December 22, 2008

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. PET occupancy with GSK1018921 [ Time Frame: 10 days ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
GSK Investigational Site
Barcelona, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Results for study 109731 can be found on the GSK Clinical Study Register. 

Study Data/Documents: Annotated Case Report Form 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00945503 History of Changes
Other Study ID Numbers:	109731
First Posted:	July 24, 2009
Last Update Posted:	July 18, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL:	http://

Keywords provided by GlaxoSmithKline:

Glycine Tranporter; MRI; PET

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glycine	Glycine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs