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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686504
First received: May 27, 2008
Last updated: December 8, 2010
Last verified: August 2008
History of Changes

May 27, 2008
December 8, 2010
April 2008
June 2008   (final data collection date for primary outcome measure)
Positron emission tomography using the radioligand radioligand [11C]AZ12713580 [ Time Frame: 4 times ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00686504 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: Yes ]
  • To investigate pharmacokinetics of AZD2066 [ Time Frame: 15 times per subject. Up to 48 hours each time ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00686504
D0475C00013, EudractCT 2008-000064-17
No
Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca R&D Södertälje, Sweden
AstraZeneca
Not Provided
Principal Investigator: Bo Fransson Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
AstraZeneca
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP