Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00788801
First received: November 7, 2008
Last updated: November 1, 2010
Last verified: September 2010
  Purpose

This study is being done in healthy volunteers to help researchers understand how ABT-614 works in the human body, specifically in the brain. The PET imaging technique can be thought of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture), a substance with low levels of radioactivity (radiotracer) has to be injected when you are in the PET camera. The radiotracer is only radioactive for a short period of time. In this study, PET is being used to measure how the study drug attaches to specific receptors in the brain. The radiotracer used in this study, [11C]-(+)-PHNO, is currently being used for studies in people at the CAMH PET Centre.


Condition Intervention Phase
Healthy Volunteers
Drug: ABT-614
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by Abbott:

Primary Outcome Measures:
  • D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP [ Time Frame: At the approximate Tmax following a single dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: December 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baseline Drug: ABT-614
Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
Experimental: ABT-614 Low Dose Drug: ABT-614
Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
Experimental: ABT-614 High Dose Drug: ABT-614
Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body Mass Index (BMI) is 18 to 26 kg/m2, inclusive
  2. A condition of general good physical health based upon the results of a medical history, physical examination, vital signs, laboratory profile, 12-lead electrocardiogram (ECG)

Exclusion Criteria:

  1. Presence of a metal implant (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker) that would preclude a MRI scan
  2. During the last year, a radiation exposure that on its own or in addition to the expected radiation from this study exceeds the allowed annual radiation exposition level (20 mV)
  3. Use of tobacco or other nicotine-containing products within 6 months prior to Screening
  4. Diagnosis of substance or alcohol disorder within 12 months prior to Screening
  5. History of claustrophobia or feeling of inability to lie still on his back in the PET camera
  6. History or presence of any neurological or psychiatric conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788801

Locations
Canada, Ontario
Site Reference ID/Investigator# 12201
Toronto, Ontario, Canada, M5T 1R8
Site Reference ID/Investigator# 13961
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Beatrice Rendenbach-Mueller, PhD/Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00788801     History of Changes
Other Study ID Numbers: M10-423
Study First Received: November 7, 2008
Last Updated: November 1, 2010
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 17, 2014