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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00686504

Acronym

PET

Enrollment

Registered

2008-05-29

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pain, PET, Phase 1, Analgesia, Positron Emission Tomography, mGlu5 receptor, Dose finding, Analgesia/Pain

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

Interventions

DRUGAZD2066

single dose of oral dose, 3 times per subject

DRUGradioligand [11C] AZ12713580

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Positron emission tomography using the radioligand radioligand [11C]AZ12713580	4 times

Secondary

Measure	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026