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
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

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. ] [ 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 ]

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)
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00686504

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov 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
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Pain
PET
Phase 1
Analgesia
Positron Emission Tomography
mGlu5 receptor
Dose finding
Analgesia/Pain

ClinicalTrials.gov processed this record on September 18, 2014