NCT01215552

Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Dart NeuroScience, LLC · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Elderly Volunteers

Interventions

Type	Name	Description
DRUG	HT-0712	A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2010-10-06
• Last updated: 2011-06-01

Locations

1 site across 1 country: United States