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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 27, 2008
Last updated: December 8, 2010
Last verified: August 2008
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 Intervention Phase
Healthy Drug: AZD2066 Drug: radioligand [11C] AZ12713580 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 6
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: May 27, 2008
Last Updated: December 8, 2010

Keywords provided by AstraZeneca:
Phase 1
Positron Emission Tomography
mGlu5 receptor
Dose finding
Analgesia/Pain processed this record on August 16, 2017