NeuroinflammationPhase 1NCT03100136
Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET Tacer
A Phase 1 study testing [11C]PF-06809247 in people with Neuroinflammation, run by Pfizer at 3 sites in United States.
Trial summary
This is a study measuring the binding kinetics and test-retest characteristics of a subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission Tomography (PET) tracer in healthy adult subjects. 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
- Neuroinflammation
- What is being tested?
- [11C]PF-06809247
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Nov 2016to 10 Mar 2017
- 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 who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- -Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease A confirmed positive urine drug test. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
- Screening supine blood pressure greater or equal than140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood. Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
- Subjects with abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment. Herbal supplements must be discontinued at least 28 days prior to the first dose of investigational product.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
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- History of sensitivity to heparin or heparin-induced thrombocytopenia. Unwilling or unable to comply with the Lifestyle Requirements described in the protocol.
- Subjects with severe claustrophobia impacting ability to perform the baseline MRI or PET scans.
- Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire (metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos). Any person unable to lie still within the environment of the MRI and PET scanners for the required period to acquire images.
- Subjects with any anatomical abnormality in the head that would either preclude or tend to confound the analysis of study data, including any clinically significant abnormal findings from MRI of the head.
- Subjects with history of prior radiation exposure for research purposes (eg, x-ray, computer tomography scans, or PET research study(ies)) within the past year Subjects with insufficient arterial patency as determined by Allen's test. Any condition possibly affecting the placement of an intravenous drug administration line, such as poor vein rating as per PCRU procedures. History of sensitivity to local anesthetics likely to be used in the placement of the arterial line.
- History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) and hepatitis C antibody (HCVAb). Male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Anylan Center
New Haven, Connecticut, 06520
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: A Non-randomized, Open-label, Exploratory Study With A Non-pharmacologically Active Dose To Evaluate The Binding Kinetics Of A Novel Monoacylglicerol Lipase Positron Emission Tomography Radiotracer [11C]PF-06809247 In Healthy Male Subjects
This is a study measuring the binding kinetics and test-retest characteristics of a subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission Tomography (PET) tracer in healthy adult subjects.
- Conditions
- Neuroinflammation
- Being tested
- [11C]PF-06809247
- Keywords
- PET, [11C]PF-06809247, Reliability, Scan, Safety
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]PF-06809247Drug
PET Tracer
| Study group | Role | What they receive |
|---|---|---|
| [11C]PF-06809247 | Experimental | A dose intravenous injection of [11C]PF-06809247 followed by PET scanning. Receives: Drug: [11C]PF-06809247 |
What is being measured
The primary outcome is the main question the study is designed to answer.
binding kinetics of the novel tracer
Binding of [11C]PF-06809247 will be assessed by the evaluation of net uptake rate constant Ki (mL/min/g) in the various brain regions modeled, as data permit.
Measured: Day 1, 0, 0:10, 0:20, 0:30, 0:40, 0:50, 1:00, 1:10, 1:20, 1:30, 1:45, 2:00, 2:15, 2:30, 2:45, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 15:00, 20:00, 25:00, 30:00, 45:00, 60:00, 75:00, 90:00, 105:00, 120:00, (min:sec)
Secondary outcomes (7)
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An assessment of Adverse Events
Measured: Day 1
Test - Retest reliability
Test-retest variability of [11C]PF-06809247 binding in the human brain will be assessed using k1, as data permit.
Measured: Day 1
Change in Physical examination
Safety test to check overall health
Measured: Day 1
Change in Neurological Exam
Assessment of sensory neuron and motor responses
Measured: Day 1
Change in 12-lead ECG (electrocardiogram)
heart's electrical activity recorded from electrodes on the body surface
Measured: Day 1
Change in Vital signs
clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
Measured: Day 1
Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start16 Nov 2016
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroinflammationStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100136
- Sponsor's protocol ID
- A9001493
- Other IDs
- PET TRACER METHODOLOGY
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Exploratory Study With A Non-pharmacologically Active Dose To Evaluate The Binding Kinetics Of A Novel Monoacylglicerol Lipase Positron Emission Tomography Radiotracer [11C]PF-06809247 In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03100136
- Acronym / sponsor ID
- A9001493
- Conditions
- Neuroinflammation
- Keywords
- PET, [11C]PF-06809247, Reliability, Scan, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2016
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
This is a study measuring the binding kinetics and test-retest characteristics of a subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission Tomography (PET) tracer in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C]PF-06809247 | Experimental | Drug: [11C]PF-06809247A dose intravenous injection of [11C]PF-06809247 followed by PET scanning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (12 listed)
- -Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease A confirmed positive urine drug test. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
- Screening supine blood pressure greater or equal than140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood. Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
- Subjects with abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment. Herbal supplements must be discontinued at least 28 days prior to the first dose of investigational product.
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 |
|---|---|---|
| [11C]PF-06809247PET Tracer | Drug | [11C]PF-06809247 |
Primary outcome
binding kinetics of the novel tracer
Time frame: Day 1, 0, 0:10, 0:20, 0:30, 0:40, 0:50, 1:00, 1:10, 1:20, 1:30, 1:45, 2:00, 2:15, 2:30, 2:45, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 15:00, 20:00, 25:00, 30:00, 45:00, 60:00, 75:00, 90:00, 105:00, 120:00, (min:sec)
Binding of [11C]PF-06809247 will be assessed by the evaluation of net uptake rate constant Ki (mL/min/g) in the various brain regions modeled, as data permit.
7 secondary outcomes
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1
Test - Retest reliability
Time frame: Day 1
Change in Physical examination
Time frame: Day 1
Change in Neurological Exam
Time frame: Day 1
Change in 12-lead ECG (electrocardiogram)
Time frame: Day 1
Change in Vital signs
Time frame: Day 1
Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
Time frame: Day 1
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 Apr 2017.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 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 [11C]PF-06809247 in people with Neuroinflammation, run by Pfizer at 3 sites in United States.
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 2 inclusion and 12 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
binding kinetics of the novel tracer (time frame: Day 1, 0, 0:10, 0:20, 0:30, 0:40, 0:50, 1:00, 1:10, 1:20, 1:30, 1:45, 2:00, 2:15, 2:30, 2:45, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 15:00, 20:00, 25:00, 30:00, 45:00, 60:00, 75:00, 90:00, 105:00, 120:00, (min:sec)). 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 Apr 2017.