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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ABT-614

• Registration Number: NCT00788801
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-11
• Study Start: 2008-12
• Primary Completion: 2009-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baseline	ABT-614	-
ABT-614 Low Dose	ABT-614	-
ABT-614 High Dose	ABT-614	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Site Reference ID/Investigator# 13961; 🇨🇦 Toronto, Ontario, Canada

Site Reference ID/Investigator# 12201; 🇨🇦 Toronto, Ontario, Canada