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View Clinical Trial (Medical Research Study)
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A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography) - NCT00939887-06519 (Clinical Trial 366135)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy366135.aspx
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06519 |
| Conditions: |
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Bipolar Disorder - Depression |
| Purpose: |
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This is a subject blind, investigator and sponsor open, randomized study consisting of 2
parts. Up to 15 healthy subjects will be included in the study. In the first part of the
study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will
be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid
receptor occupancy (RO) will be assessed in up to three cohorts of subjects.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 and 55 years, inclusive. (Healthy is defined as no clinically relevant
abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12 lead ECG and clinical
laboratory tests.)
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen at Screening or Day 0.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men.
- Use of tobacco- or nicotine-containing products within 3 months of screening.
- Treatment with an investigational drug within 30 days or 5 half lives preceding the
first dose of study medication (excluding [11C]PF 04767135).
- 12 lead ECG demonstrating QTc >450 msec at Screening.
- Pregnant or nursing females; females of childbearing potential. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 2, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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