Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066
PET
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
2 other identifiers
interventional
6
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Apr 2008
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 10, 2010
August 1, 2008
2 months
May 27, 2008
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positron emission tomography using the radioligand radioligand [11C]AZ12713580
4 times
Secondary Outcomes (2)
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
Interventions
single dose of oral dose, 3 times per subject
single dose of iv administered 4 times per subject (3 times together with AZD2066)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Stockholm, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Fransson
Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
- STUDY DIRECTOR
Sophia Bengtsson
AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 10, 2010
Record last verified: 2008-08