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

Dart NeuroScience

Status and phase

Terminated

Phase 1

Conditions

Healthy Elderly Volunteers

Treatments

Drug: HT-0712

Study type

Interventional

Funder types

Industry

Identifiers

NCT01215552

BNL IRB #444 (Other Identifier)

HT-0712-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

55 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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