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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686504
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : December 10, 2010
Information provided by:

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD2066 Drug: radioligand [11C] AZ12713580 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Intervention Details:
  • Drug: AZD2066
    single dose of oral dose, 3 times per subject
  • Drug: radioligand [11C] AZ12713580
    single dose of iv administered 4 times per subject (3 times together with AZD2066)

Primary Outcome Measures :
  1. Positron emission tomography using the radioligand radioligand [11C]AZ12713580 [ Time Frame: 4 times ]

Secondary Outcome Measures :
  1. 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. ]
  2. To investigate pharmacokinetics of AZD2066 [ Time Frame: 15 times per subject. Up to 48 hours each time ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00686504

Research Site
Stockholm, Sweden
Sponsors and Collaborators
Principal Investigator: Bo Fransson Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca R&D Södertälje, Sweden Identifier: NCT00686504     History of Changes
Other Study ID Numbers: D0475C00013
EudractCT 2008-000064-17
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: August 2008

Keywords provided by AstraZeneca:
Phase 1
Positron Emission Tomography
mGlu5 receptor
Dose finding