- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681746
Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 (PET)
December 8, 2010 updated by: AstraZeneca
An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 After Oral Administration to Healthy Volunteers
The study is carried out in order to determine the relationship between the dose of AZD6280 and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to GABAA receptors
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Stockholm, Sweden
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
- Clinically normal physical findings, medical history and laboratory values.
Exclusion Criteria:
- Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
- History of clinically significant heart arrythmias or heart disease/problems.
- Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Single dose of oral solution or capsule(s).
3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.
Single dose of intravenous solution.
4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects.
(once together with AZD6280)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positron emission tomography using the radioligand (11C) flumazenil
Time Frame: 4 times per subject
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4 times per subject
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, psychometric tests and laboratory variables.
Time Frame: 6 visits with tests for the 2 subjects in the first group (Panel 1). 4 visits with tests for the 6 remaining subjects. Some tests will be done several times per visit. All tests will not be done at every visit.
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6 visits with tests for the 2 subjects in the first group (Panel 1). 4 visits with tests for the 6 remaining subjects. Some tests will be done several times per visit. All tests will not be done at every visit.
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Investigate the pharmacokinetics of AZD6280 following single doses of AZD6280 by assessment of drug concentration in plasma.
Time Frame: 3 times for the 2 subjects in the first group (Panel 1). Once for the 6 remaining subjects. Up to 48 hours at each time.
|
3 times for the 2 subjects in the first group (Panel 1). Once for the 6 remaining subjects. Up to 48 hours at each time.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Fransson, Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
- Study Director: Eva Taavo, AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 10, 2010
Last Update Submitted That Met QC Criteria
December 8, 2010
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0850C00011
- EudractCT 2007-006683-29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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