Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anxiety

Intervention / Treatment
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* Drug: AZD7325
* Drug: Radioligand (11C) flumazenil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7325<br>* Single dose of oral solution or capsule. 3 times per subject.<br>Drug: Radioligand (11C) flumazenil<br>* Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography using the radioligand (11C)flumazenil |  | 4 times per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables. |  | 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 | 
| Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma |  | 3 times per subject. Up to 48 hours each time. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, GABA receptors, Positron Emission Tomography, PET, phase I