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Completed

NCT Number: NCT00788801

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 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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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 12201, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) is 18 to 26 kg/m2, inclusive
  • 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

  • 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
  • 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)
  • Use of tobacco or other nicotine-containing products within 6 months prior to Screening
  • Diagnosis of substance or alcohol disorder within 12 months prior to Screening
  • History of claustrophobia or feeling of inability to lie still on his back in the PET camera
  • History or presence of any neurological or psychiatric conditions

Treatment and study plan

ABT-614

Drug

Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Nov 11, 2008
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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