Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
1 other identifier
interventional
11
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedNovember 2, 2010
September 1, 2010
3 months
November 7, 2008
November 1, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP
At the approximate Tmax following a single dose of study drug
Study Arms (3)
Baseline
EXPERIMENTALABT-614 Low Dose
EXPERIMENTALABT-614 High Dose
EXPERIMENTALInterventions
Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (2)
Site Reference ID/Investigator# 12201
Toronto, Ontario, M5T 1R8, Canada
Site Reference ID/Investigator# 13961
Toronto, Ontario, M5V 2T3, Canada
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
November 7, 2008
First Posted
November 11, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2009
Last Updated
November 2, 2010
Record last verified: 2010-09