Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Baseline
Intervention: ABT-614 (Drug)
ABT-614 Low Dose
Intervention: ABT-614 (Drug)
ABT-614 High Dose
Intervention: ABT-614 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported