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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00681746 |
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
Condition | Intervention | Phase |
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Anxiety |
Drug: AZD6280 Drug: (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 AZD6280 After Oral Administration to Healthy Volunteers |
Estimated Enrollment: | 8 |
Study Start Date: | February 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AZD6280
Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.
Drug: (11C) flumazenil
Single dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)
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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 Pharmaceuticals ( Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry ) |
Study ID Numbers: | D0850C00011, EudractCT 2007-006683-29 |
Study First Received: | May 16, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00681746 |
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 |