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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00686504
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-08
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positron emission tomography using the radioligand radioligand [11C]AZ12713580	4 times

Secondary Outcome Measures

Name	Time	Method
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.
To investigate pharmacokinetics of AZD2066	15 times per subject. Up to 48 hours each time

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden