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:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00788801
First received: November 7, 2008
Last updated: November 1, 2010
Last verified: September 2010
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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:
- 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
Contacts and Locations 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 May 22, 2013