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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00681720 |
The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.
Condition | Intervention | Phase |
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Anxiety |
Drug: AZD7325 Drug: Radioligand (11C) flumazenil |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 After Oral Administration to Healthy Volunteers |
Enrollment: | 4 |
Study Start Date: | February 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AZD7325
Single dose of oral solution or capsule. 3 times per subject.
Drug: Radioligand (11C) flumazenil
Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)
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Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Research Site | |
Stockholm, Sweden |
Principal Investigator: | Bo Fransson | AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden |
Study Director: | Eva Taavo | AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden |
Responsible Party: | AstraZeneca ( Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry ) |
Study ID Numbers: | D1140C00007, EudractCT 2007-005436-86 |
Study First Received: | May 19, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681720 |
Health Authority: | Sweden: Medical Products Agency |
Anxiety GABA receptors Positron Emission Tomography PET phase I |
Flumazenil Healthy |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs |
GABA Agents Protective Agents Pharmacologic Actions Antidotes |