Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681720
First received: May 19, 2008
Last updated: August 20, 2008
Last verified: August 2008
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Purpose
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 |
|---|---|---|
|
Anxiety |
Drug: AZD7325 Drug: Radioligand (11C) flumazenil |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Positron emission tomography using the radioligand (11C)flumazenil [ Time Frame: 4 times per subject ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables. [ Time Frame: 6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit ] [ Designated as safety issue: No ]
- Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma [ Time Frame: 3 times per subject. Up to 48 hours each time. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: 1 |
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)
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
- Intake of another investigational drug or participation in a clinical study the past 12 weeks.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681720
Locations
| Sweden | |
| Research Site | |
| Stockholm, Sweden | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Bo Fransson | AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden |
| Study Director: | Eva Taavo | AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden |
More Information
No publications provided
| Responsible Party: | Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00681720 History of Changes |
| Other Study ID Numbers: | D1140C00007, EudractCT 2007-005436-86 |
| Study First Received: | May 19, 2008 |
| Last Updated: | August 20, 2008 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
|
Anxiety GABA receptors Positron Emission Tomography PET phase I |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Flumazenil GABA Modulators GABA Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013