Trial record 1 of 2 for:    HT-0712
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Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01215552
Recruitment Status : Terminated (The experimental design was not sufficient to answer the proposed questions. A new study design is now being considered.)
First Posted : October 6, 2010
Last Update Posted : June 1, 2011
Information provided by:
Dart NeuroScience, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Elderly Volunteers Drug: HT-0712 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: HT-0712 Drug: HT-0712
A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules

Primary Outcome Measures :
  1. PET measurement of HT-0712 inhibition of [11C]R-rolipram binding [ Time Frame: 1 day ]
    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.

Secondary Outcome Measures :
  1. 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 Frame: 1 day ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01215552

United States, New York
Brookhaven National Laboratory
Upton, New York, United States, 11973
Sponsors and Collaborators
Dart NeuroScience, LLC
Study Director: Philip Perera, MD Dart NeuroScience, LLC

Responsible Party: Dr. Philip Perera, MD, Helicon Therapeutics Identifier: NCT01215552     History of Changes
Other Study ID Numbers: HT-0712-006
BNL IRB #444 ( Other Identifier: Brookhaven National Laboratory )
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action