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

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ClinicalTrials.gov Identifier: NCT00945503
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 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

Resource links provided by the National Library of Medicine

Drug Information available for: Glycine
U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945503


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

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109731
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
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    Key Record Dates
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