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:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00945503
First received: July 23, 2009
Last updated: July 30, 2009
Last verified: July 2009
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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:
MedlinePlus 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 ] [ 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 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 Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013