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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

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

Detailed Description

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Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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AZD2066

single dose of oral dose, 3 times per subject

Intervention Type DRUG

radioligand [11C] AZ12713580

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

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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AstraZeneca R&D Södertälje, Sweden

Principal Investigators

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Bo Fransson

Role: PRINCIPAL_INVESTIGATOR

Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden

Sophia Bengtsson

Role: STUDY_DIRECTOR

AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudractCT 2008-000064-17

Identifier Type: -

Identifier Source: secondary_id

D0475C00013