A Phase 1 interventional study of HT-0712 in Healthy Elderly Volunteers, sponsored by Dart NeuroScience, LLC. Terminated at 1 site in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-01.
Sponsored by Dart NeuroScience, LLC · Phase 1, Interventional, and Basic science
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.
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.
Main Inclusion Criteria:
Main Exclusion Criteria:
Drug: HT-0712
A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules
PET measurement of HT-0712 inhibition of [11C]R-rolipram binding
To demonstrate Central Nervous System (CNS) exposure and dose-related inhibition of \[11C\]R-rolipram binding in brain regions of interest by HT-0712 when compared to baseline \[11C\]R-rolipram binding in the same individual.
Time frame: 1 day
Brain uptake of [11C]R-rolipram, as determined by PET imaging, associated with both maximal plasma concentration of HT-0712 (Tmax) and overall plasma level exposure (AUC) following administration of different dose levels of HT-0712.
Time-activity curves and plasma AUC will be assessed for \[11C\]R-rolipram at baseline and at 4-hours post oral administration of HT-0712.
Time frame: 1 day
This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Dart NeuroScience, LLC