Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET Tacer
NCT03100136
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
Adult Trials: 18+ Years
- 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).
-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.
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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET Tacer | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | |||
| Condition ICMJE | Neuroinflammation | |||
| Intervention ICMJE | Drug: [11C]PF-06809247
PET Tracer | |||
| Study Arms ICMJE | Experimental: [11C]PF-06809247
A dose intravenous injection of [11C]PF-06809247 followed by PET scanning. Intervention: Drug: [11C]PF-06809247 | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 7 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | March 10, 2017 | |||
| Actual Primary Completion Date | March 10, 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: -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. 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 | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT03100136 | |||
| Other Study ID Numbers ICMJE | A9001493 PET TRACER METHODOLOGY ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||