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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788801
• Other study ID #: M10-423
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2008
• Last updated: November 1, 2010
• Start date: December 2008

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 12201	Toronto	Ontario
Canada	Site Reference ID/Investigator# 13961	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No