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

Anxiety Clinical Trial

— PET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681720
• Other study ID #: D1140C00007
• Secondary ID: EudractCT 2007-0
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2008
• Last updated: August 20, 2008
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety

Intervention

Drug:
• AZD7325
Single dose of oral solution or capsule. 3 times per subject.
• Radioligand (11C) flumazenil
Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography using the radioligand (11C)flumazenil		4 times per subject	No
Secondary	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	No
Secondary	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.	No