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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

NCT ID: NCT00788801

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Baseline

Group Type EXPERIMENTAL

ABT-614

Intervention Type DRUG

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

ABT-614 Low Dose

Group Type EXPERIMENTAL

ABT-614

Intervention Type DRUG

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

ABT-614 High Dose

Group Type EXPERIMENTAL

ABT-614

Intervention Type DRUG

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

Interventions

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ABT-614

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 12201

Toronto, Ontario, Canada

Site Status

Site Reference ID/Investigator# 13961

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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M10-423

Identifier Type: -

Identifier Source: org_study_id