Mild Cognitive ImpairmentPhase 1NCT00474513
An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.
A Phase 1 study testing GSK239512 in people with Mild Cognitive Impairment and Dementia, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy). Read more about this study
- Who is it for?
- Ages 35 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- GSK239512
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Mar 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 35 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged 35 to 49 inclusive at the screening visit.
- Healthy, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, laboratory studies, and other tests as judged by the investigator.
- Body weight ≥ 50 kg and BMI within the range of 19-29 kg/m2, inclusive.
- Normal thyroid function tests as judged by the investigator.
- Willingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or willingness to use adequate contraception the time of the first dose of [11C]GSK189254 until completion of the study and for 84 days following the study.
- Capable of giving informed consent and can comply with the study requirements and timetable.
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- The subject must be able to read, comprehend and record information.
- A signed and dated written informed consent is obtained from the subject prior to taking part in the study.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- The subject must have a QTc<450msec (for males) or <480 msec for subjects with bundle branch block
Who cannot join
- The subject has used or is using regular prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within fourteen days or five half lives (whichever was the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication would not have interfered with the study procedures or compromised subject safety. Medications considered to be unlikely to interfere with the study are, thyroid replacement therapy, laxatives, occasional use of vitamin supplements, PRN paracetamol and NSAIDs, prophylactic aspirin.
- The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
- History of heavy use (>10 per day) of tobacco or nicotine-containing products within six months of the start of the study.
- Heavy use of caffeine (>6 cups of caffeinated beverage per day).
- The subject had a history or presence of drug or other significant allergy that, in the opinion of the responsible physician, contra-indicated their participation.
- History or presence of neurological or significant psychiatric disease, such as depressive disorder (as defined by HAD depression score >8) or anxiety disorder (as defined by HAD anxiety score >8) See Appendix 7.
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- The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- The subject has donated blood (450 mL) within the last three months before the study.
- The subject has participated in a clinical study with an investigational or a non- investigational drug or device during the previous three months or has participated in more than three studies in the previous year.
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with a significant radiation burden that, in combination with the PET scans, may result in the subject receiving more than 10mSv over the previous 3 years.
- History or presence of neurological or psychiatric conditions (e.g., stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results or compromise subject safety.
- Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire.
- History of known or suspected seizures, unexplained significant loss of consciousness or history of significant head trauma with loss of consciousness. Subjects who had febrile seizures in childhood may be included if these have ceased by age 5 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
- Allen's test result leading to concern about the patency of both the radial and ulnar arteries in the wrist that is being used for arterial cannulation.
- Needle phobia or fear of arterial blood sampling.
- A positive HIV-1/2, hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
- Subjects with a QTc of >500 msec.
- Subjects with a known history or presence of sleep disorders based on investigator review of medical history and symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PET Study Using [11C] GSK189254 to Establish the Dose, Plasma Concentration and Brain Receptor Occupancy Relationship of GSK239512, a Histamine H3 Antagonist, in Healthy Subjects
GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy). This study will use the technique of positron emission tomography (PET) as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and subsequently bound to receptors, after receiving an oral dose of the drug. It will also look at the rate the drug dissociates from the receptors in the brain. Results from the study will provide information on doses of the drug to be given in further studies.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- GSK239512
- Keywords
- AD, H3, Brain, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK239512Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET images at 4 hours and 24 hours post dose
Secondary outcomes (1)
Safety of drug and concentration of GSK239512 in the blood at various timepoints. Using vital signs and ECG, clinical laboratory assessments and PK sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT00474513
- Sponsor's protocol ID
- H3B106026
- Status last verified
- Feb 2011
- First submitted
- 15 May 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PET Study Using [11C] GSK189254 to Establish the Dose, Plasma Concentration and Brain Receptor Occupancy Relationship of GSK239512, a Histamine H3 Antagonist, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00474513
- Acronym / sponsor ID
- H3B106026
- Conditions
- Mild Cognitive Impairment, Dementia
- Keywords
- AD, H3, Brain, Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 May 2007 (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.
GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy). This study will use the technique of positron emission tomography (PET) as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and subsequently bound to receptors, after receiving an oral dose of the drug. It will also look at the rate the drug dissociates from the receptors in the brain. Results from the study will provide information on doses of the drug to be given in further studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male aged 35 to 49 inclusive at the screening visit.
- Healthy, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, laboratory studies, and other tests as judged by the investigator.
- Body weight ≥ 50 kg and BMI within the range of 19-29 kg/m2, inclusive.
- Normal thyroid function tests as judged by the investigator.
- Willingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or willingness to use adequate contraception the time of the first dose of [11C]GSK189254 until completion of the study and for 84 days following the study.
Key exclusion criteria (18 listed)
- The subject has used or is using regular prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within fourteen days or five half lives (whichever was the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication would not have interfered with the study procedures or compromised subject safety. Medications considered to be unlikely to interfere with the study are, thyroid replacement therapy, laxatives, occasional use of vitamin supplements, PRN paracetamol and NSAIDs, prophylactic aspirin.
- The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
- History of heavy use (>10 per day) of tobacco or nicotine-containing products within six months of the start of the study.
- Heavy use of caffeine (>6 cups of caffeinated beverage per day).
- The subject had a history or presence of drug or other significant allergy that, in the opinion of the responsible physician, contra-indicated their participation.
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 |
|---|---|---|
| GSK239512 | Drug | – |
Primary outcome
Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET images at 4 hours and 24 hours post dose
1 secondary outcome
Safety of drug and concentration of GSK239512 in the blood at various timepoints. Using vital signs and ECG, clinical laboratory assessments and PK sampling.
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 4 Jun 2012.
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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 GSK239512 in people with Mild Cognitive Impairment and Dementia, run by GlaxoSmithKline at 1 site in Canada.
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 10 inclusion and 18 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 4 Jun 2012. 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 Canada. 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?
Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET images at 4 hours and 24 hours post dose. 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 4 Jun 2012.