Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066 (PET)

December 8, 2010 updated by: AstraZeneca

An Open Label, Non-randomized Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066 After Oral Administration to Healthy Subjects

The study is carried out in order to determine the relationship between AZD2066 exposure and mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace [11C]AZ12713580 from mGluR5 binding-sites in the Central Nervous System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent
  • BMI (Body Mass Index) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
  • Normal MRI (Magnetic Resonance Imaging) scan at visit 2

Exclusion Criteria:

  • History of previous or ongoing psychiatric disease or condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
  • History of psychotic disorder among first degree relatives (parents, siblings)
  • History of use of antipsychotic, antidepressant or anxiolytic (anxiety treatment) drugs, prescribed or non-prescribed use. History of antidepressants or anxiolytics for non-psychiatric conditions such as pain or post-operative insomnia is allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positron emission tomography using the radioligand radioligand [11C]AZ12713580
Time Frame: 4 times
4 times

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety and tolerability of AZD2066 by assessment of Adverse Events (AEs), vital signs measurements (blood pressure and pulse), electrocardiogram (ECG), physical examination, clinical chemistry, haematology and urinalysis.
Time Frame: 7 visits with tests for all subjects. Some tests will be done several times per visit. All tests will not be performed at every visit.
7 visits with tests for all subjects. Some tests will be done several times per visit. All tests will not be performed at every visit.
To investigate pharmacokinetics of AZD2066
Time Frame: 15 times per subject. Up to 48 hours each time
15 times per subject. Up to 48 hours each time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Bo Fransson, Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
  • Study Director: Sophia Bengtsson, AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0475C00013
  • EudractCT 2008-000064-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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