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

Phase 1

Completed

• Conditions: Anxiety
• Interventions: Drug: AZD7325; Drug: Radioligand (11C) flumazenil

• Registration Number: NCT00681720
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD7325	-
1	Radioligand (11C) flumazenil	-

Primary Outcome Measures

Name	Time	Method
Positron emission tomography using the radioligand (11C)flumazenil	4 times per subject

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden