Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
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.
1 other identifier
interventional
12
1 country
1
Brief Summary
A PET study using \[11c\]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 schizophrenia
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2008
CompletedFirst Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedJuly 18, 2017
July 1, 2017
7 months
July 23, 2009
July 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PET occupancy with GSK1018921
10 days
Secondary Outcomes (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.
10 days
Study Arms (1)
GSK1018921
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- Age: 18-55 years
- No history of physical, neurological or mental illness
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Barcelona, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
May 19, 2008
Primary Completion
December 22, 2008
Study Completion
December 22, 2008
Last Updated
July 18, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.