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

November 7, 2008
November 1, 2010
December 2008
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00788801 on ClinicalTrials.gov Archive Site
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Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
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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.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
Drug: ABT-614
Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
  • Experimental: Baseline
    Intervention: Drug: ABT-614
  • Experimental: ABT-614 Low Dose
    Intervention: Drug: ABT-614
  • Experimental: ABT-614 High Dose
    Intervention: Drug: ABT-614
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
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March 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00788801
M10-423
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Beatrice Rendenbach-Mueller, PhD/Project Director, Abbott
Abbott
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Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP