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A PET Study: Single-dose, Open-label Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712
| City: |
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Upton |
| State: |
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New York |
| Zip Code: |
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11973 |
| Conditions: |
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Healthy Elderly Volunteers |
| Purpose: |
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This Positron Emission Tomography (PET) imaging study is designed to explore the
relationship between HT-0712 dose level and inhibition of brain phosphodiesterase-4
activity, in order to optimize the dosage regimens utilized in subsequent trials.
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| Study Summary: |
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The objective of this project is to demonstrate the inhibition of human brain PDE4 by
HT-0712, by measuring the inhibition of [11C]R-rolipram binding, a radiotracer which also
binds to and inhibits PDE4. Plasma samples will be drawn to determine if there is a
relationship between plasma pharmacokinetics of HT-0712 and its pharmacodynamic effect, as
determined through the inhibition of [11C]R-rolipram binding in the brain.
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| Criteria: |
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Main Inclusion Criteria:
- Healthy, elderly, non-smoking men and post-menopausal women
- Ability to give informed consent
Main Exclusion Criteria:
- Current or history of uncontrolled hypertension, major depression, Parkinson's
disease, stroke and diabetes.
- Physical or behavioral conditions that may alter brain function
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| NCT ID: |
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NCT01215552 |
| Primary Contact: |
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Study Director
Philip Perera, MD
Helicon Therapeutics, Inc.
Helicon Therapeutics
Phone: 858-246-8144
Email: clinicaltrials@helicontherapeutics.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Upton, New York 11973
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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