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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00686504

Purpose

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	Intervention	Phase
Healthy	Drug: AZD2066 Drug: radioligand [11C] AZ12713580	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Positron emission tomography using the radioligand radioligand [11C]AZ12713580 [ Time Frame: 4 times ] [ Designated as safety issue: No ]

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. [ 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. ] [ Designated as safety issue: Yes ]
To investigate pharmacokinetics of AZD2066 [ Time Frame: 15 times per subject. Up to 48 hours each time ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

single dose of oral dose, 3 times per subject

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

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686504

Locations

Sweden
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

More Information

Responsible Party:	AstraZeneca R&D Södertälje, Sweden ( Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia )
Study ID Numbers:	D0475C00013, EudractCT 2008-000064-17
Study First Received:	May 27, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00686504
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Pain
PET
Phase 1
Analgesia

Positron Emission Tomography
mGlu5 receptor
Dose finding
Analgesia/Pain

Study placed in the following topic categories:

Signs and Symptoms
Pain
Healthy

ClinicalTrials.gov processed this record on January 16, 2009