An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

This study is currently recruiting participants.

Verified by AstraZeneca, May 2009

First Received: April 28, 2009 Last Updated: May 4, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00892944

Purpose

The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.

Condition	Intervention	Phase
Healthy	Drug: AZD2516	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy [ Time Frame: 1 Month: Baseline and 3 PET examinations ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables [ Time Frame: Assessed at each visit from baseline to follow-up visit ] [ Designated as safety issue: No ]
To investigate the Pharmacokinetics of AZD2516 [ Time Frame: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Experimental AZD2516	Drug: AZD2516 Fractionated single oral dose

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal MRI scan
Healthy male or non-fertile females
Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

History of disease or condition that may interfere with the objectives of the study
History of previous or ongoing psychiatric disease/condition
Concomitant medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892944

Contacts

Contact: AstraZeneca Clinical Study Information	: 800-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Information, (Outside US)	001-800-236-9933

Locations

Sweden
Research Site	Recruiting
Stockholm, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Ingemar Bylesjo, MD, PhD	AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director:	Michael O'Malley	AstraZeneca R&D, Södertälje, Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca ( MSD )
Study ID Numbers:	D2080C00009
Study First Received:	April 28, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00892944 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Positron Emission Tomography
Phase 1
Healthy volunteers
AZD2516

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009