NCT01215552

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

September 24, 2010

Last Update Submit

May 27, 2011

Conditions

Healthy Elderly Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (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.

    1 day

Study Arms (1)

HT-0712

EXPERIMENTAL
Drug: HT-0712

Interventions

HT-0712DRUG

A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules

HT-0712

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, elderly, non-smoking men and post-menopausal women
  • Ability to give informed consent

You may not qualify if:

  • Current or history of uncontrolled hypertension, major depression, Parkinson's disease, stroke and diabetes.
  • Physical or behavioral conditions that may alter brain function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brookhaven National Laboratory

Upton, New York, 11973, United States

Location

MeSH Terms

Interventions

HT-0712

Study Officials

  • Philip Perera, MD

    Dart NeuroScience, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2010

First Posted

October 6, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

US(1)