Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280

Anxiety Clinical Trial

— PET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681746
• Other study ID #: D0850C00011
• Secondary ID: EudractCT 2007-0
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2008
• Last updated: December 8, 2010
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: November 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 AZD6280 and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to GABAA receptors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2008
• Est. primary completion date: September 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.

• History of clinically significant heart arrythmias or heart disease/problems.

• 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:
• AZD6280
Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.
• (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)

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, psychometric tests and laboratory variables.		6 visits with tests for the 2 subjects in the first group (Panel 1). 4 visits with tests for the 6 remaining subjects. Some tests will be done several times per visit. All tests will not be done at every visit.	No
Secondary	Investigate the pharmacokinetics of AZD6280 following single doses of AZD6280 by assessment of drug concentration in plasma.		3 times for the 2 subjects in the first group (Panel 1). Once for the 6 remaining subjects. Up to 48 hours at each time.	No