SchizophreniaPhase 1NCT00945503
Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
A Phase 1 study testing GSK1018921 in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Spain.
Trial summary
A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- GSK1018921
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 19 May 2008to 22 Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Age: 18-55 years
- No history of physical, neurological or mental illness
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- GSK1018921
- Keywords
- Glycine Tranporter, MRI, PET
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1018921Drug
GSK1018921 is a GT1 recepor antagonist
| Study group | Role | What they receive |
|---|---|---|
| GSK1018921 | Experimental | 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. Receives: Drug: GSK1018921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET occupancy with GSK1018921
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study start19 May 2008
- Primary completion22 Dec 2008
- Study completion22 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945503
- Sponsor's protocol ID
- 109731
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2009
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00945503
- Acronym / sponsor ID
- 109731
- Conditions
- Schizophrenia
- Keywords
- Glycine Tranporter, MRI, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 May 2008 (actual)
- Primary completion
- 22 Dec 2008 (actual)
- Study completion
- 22 Dec 2008 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1018921 | Experimental | Drug: GSK1018921All 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1018921GSK1018921 is a GT1 recepor antagonist | Drug | GSK1018921 |
Primary outcome
PET occupancy with GSK1018921
Time frame: 10 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 109731 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1018921 in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET occupancy with GSK1018921 (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.