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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00788801

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment

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 ]

Estimated Enrollment:	12
Study Start Date:	December 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-614 A total of 7 single doses will be given. The first single dose is 3mg, the second single dose is 6mg, the remaining dose will be given in increments of 10 up to 50mg

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male, between 18 and 40 years of age, inclusive
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 camera6. History or presence of any neurological or psychiatric conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788801

Contacts

Contact: Nicole Rodell

847-937-3891

nicole.rodell@abbott.com

Locations

Canada, Ontario
	Recruiting
Toronto, Ontario, Canada
Contact 1-866-222-8063
	Active, not recruiting
Toronto, Ontario, Canada, M6J 1H4

Sponsors and Collaborators

Abbott

More Information

Responsible Party:	Abbott ( Dr Earle Bain, Medical Director )
Study ID Numbers:	M10-423
Study First Received:	November 7, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00788801
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009