Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00788801

Enrollment

Registered

2008-11-11

Start date

2008-12-31

Completion date

Unknown

Last updated

2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGABT-614

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026