Last updated: 11/07/2018 02:45:46
Positron Emission Tomography (PET) study to describe the relationship between plasma concentrations and brain Gly-T1 occupancy of GSK1018921 over time.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
PET occupancy with GSK1018921
Timeframe: 10 days
Secondary outcomes:
To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests.
Timeframe: 10 days
Interventions:
Drug: GSK1018921
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Roger Gunn, Venkatesha Murthy, Anna Catafau, Graham Searle, Santiago Bullich, Mark Slifstein, Danielle Ouellet, Stefano Zamuner, Raul Herance, Cristian Salinas, Ricardo Pardo-Lozano, Eugenii Rabiner, Magi Farre, Marc Laruelle. Translational Characterization of 11CGSK931145, a PET Ligand for the Glycine Transporter Type 1 (GlyT-1).. Synapse. 2011;65(12):1319-1332.
Medical condition
Schizophrenia
Product
GSK1018921
Collaborators
Not applicable
Study date(s)
May 2008 to December 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Inclusion criteria:
- Healthy male subjects
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Inclusion criteria: -Healthy male subjects -Age: 18-55 years -No history of physical, neurological or mental illness
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-22-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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