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

AstraZeneca6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD2066DRUG

single dose of oral dose, 3 times per subject

radioligand [11C] AZ12713580DRUG

single dose of iv administered 4 times per subject (3 times together with AZD2066)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

Positron emission tomography using the radioligand radioligand [11C]AZ12713580

Time frame: 4 times

Secondary Outcomes

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.

To investigate pharmacokinetics of AZD2066

Time frame: 15 times per subject. Up to 48 hours each time

Data from ClinicalTrials.gov

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