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

Phase 1

Completed

• Conditions: Anxiety
• Interventions: Drug: AZD6280; Drug: (11C) flumazenil

• Registration Number: NCT00681746
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD6280	-
1	(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, 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.
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden