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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD2066
* Drug: radioligand [11C] AZ12713580


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography using the radioligand radioligand [11C]AZ12713580 |  | 4 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, PET, Phase 1, Analgesia, Positron Emission Tomography, mGlu5 receptor, Dose finding, Analgesia/Pain