Cognitive DisordersPhase 1NCT00937846
Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study
A Phase 1 study testing GSK1034702 in people with Cognitive Disorders, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET). Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- GSK1034702
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Jul 2009to 28 Aug 2009
- 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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy.
- Male between 35 and 55 years of age.
- Willing to use appropriate contraception method.
- Weight more than 50 kg.
- BMI within the range 19 - 29 kg/m2.
- Adequate blood supply to the hand.
Who cannot join
- Abuse of drugs or alcohol.
- Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
- ECG abnormality (personal or family history).
- Psychiatric disorder.
- Asthma or a history of asthma.
- Medical illness.
Show all 10Show fewer
- Worked as a welder, metal worker or machinist.
- Suffers from claustrophobia or would be unable to lie still in a PET or MRI scanner for 1-2 hours.
- Has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies.
- Neurological disorder
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
London, W12 ONN
About this study
Official title: An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).
Read the detailed description
This is an open label, single dose, non-randomized PET study in healthy male subjects to ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central effect. GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the distribution of GSK1034702 into human brain could be adversely affected. This use of PET in conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg. Subjects will have an MRI scan to aid definition of brain anatomy, a baseline PET scan and a post-dose PET scan. For each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.
- Conditions
- Cognitive Disorders
- Being tested
- GSK1034702
- Keywords
- Cognitive impairment, Schizophrenia, Alzheimer's Disease, PET
- Medical subject headings
- Cognitive Dysfunction, Schizophrenia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1034702Drug
Single oral 5 mg dose in liquid formulation
| Study group | Role | What they receive |
|---|---|---|
| GSK1034702 | Experimental | Single oral 5 mg dose in liquid formulation Receives: Drug: GSK1034702 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
Measured: Scanning day
Secondary outcomes (3)
The kinetic rate constants at tracer and pharmacological doses.
Measured: Scanning day
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
Measured: Scanning day
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study start15 Jul 2009
- Primary completion28 Aug 2009
- Study completion28 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DisordersStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT00937846
- Sponsor's protocol ID
- 110771
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2009
- Last updated
- 27 Jun 2017
- Results posted
- 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.
Publications
Ridler K, Cunningham V, Huiban M, Martarello L, Pampols-Maso S, Passchier J, Gunn RN, Searle G, Abi-Dargham A, Slifstein M, Watson J, Laruelle M, Rabiner EA. An evaluation of the brain distribution of [(11)C]GSK1034702, a muscarinic-1 (M 1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014 Dec;4(1):66. doi: 10.1186/s13550-014-0066-y. Epub 2014 Dec 5.
PubMed 26116126
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00937846
- Acronym / sponsor ID
- 110771
- Conditions
- Cognitive Disorders
- Keywords
- Cognitive impairment, Schizophrenia, Alzheimer's Disease, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2009 (actual)
- Primary completion
- 28 Aug 2009 (actual)
- Study completion
- 28 Aug 2009 (actual)
- First posted
- 13 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.
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).
Detailed description
This is an open label, single dose, non-randomized PET study in healthy male subjects to ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central effect. GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the distribution of GSK1034702 into human brain could be adversely affected. This use of PET in conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg. Subjects will have an MRI scan to aid definition of brain anatomy, a baseline PET scan and a post-dose PET scan. For each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1034702 | Experimental | Drug: GSK1034702Single oral 5 mg dose in liquid formulation |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Generally healthy.
- Male between 35 and 55 years of age.
- Willing to use appropriate contraception method.
- Weight more than 50 kg.
- BMI within the range 19 - 29 kg/m2.
Key exclusion criteria (10 listed)
- Abuse of drugs or alcohol.
- Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
- ECG abnormality (personal or family history).
- Psychiatric disorder.
- Asthma or a history of asthma.
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 |
|---|---|---|
| GSK1034702Single oral 5 mg dose in liquid formulation | Drug | GSK1034702 |
Primary outcome
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
Time frame: Scanning day
3 secondary outcomes
The kinetic rate constants at tracer and pharmacological doses.
Time frame: Scanning day
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
Time frame: Scanning day
Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
Time frame: 2 weeks
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 27 Jun 2017.
- Derived from this study: PubMed 26116126Ridler K, Cunningham V, Huiban M, Martarello L, Pampols-Maso S, Passchier J, Gunn RN, Searle G, Abi-Dargham A, Slifstein M, Watson J, Laruelle M, Rabiner EA. An evaluation of the brain distribution of [(11)C]GSK1034702, a muscarinic-1 (M 1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014 Dec;4(1):66. doi: 10.1186/s13550-014-0066-y. Epub 2014 Dec 5.
- Results for study 110771 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1034702 in people with Cognitive Disorders, run by GlaxoSmithKline at 2 sites in United Kingdom.
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 6 inclusion and 10 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses. (time frame: Scanning day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937846, which also lists 1 linked publication.
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 27 Jun 2017.