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

Healthy Clinical Trial

— PET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686504
• Other study ID #: D0475C00013
• Secondary ID: EudractCT 2008-0
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2008
• Last updated: December 8, 2010
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography using the radioligand radioligand [11C]AZ12713580		4 times	No
Secondary	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.		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.	Yes
Secondary	To investigate pharmacokinetics of AZD2066		15 times per subject. Up to 48 hours each time	No