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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00686504

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD2066 Drug: radioligand [11C] AZ12713580	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Stockholm		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Bo Fransson, Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson, AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden