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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681746

Purpose

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

Condition	Intervention	Phase
Anxiety	Drug: AZD6280 Drug: (11C) flumazenil	Phase I

MedlinePlus related topics: Anxiety

Drug Information available for: Flumazenil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Positron emission tomography using the radioligand (11C) flumazenil [ Time Frame: 4 times per subject ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, psychometric tests and laboratory variables. [ Time Frame: 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. ] [ Designated as safety issue: No ]
Investigate the pharmacokinetics of AZD6280 following single doses of AZD6280 by assessment of drug concentration in plasma. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	February 2008
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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. Drug: (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)

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681746

Locations

Sweden
Research Site
Stockholm, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Bo Fransson	AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director:	Eva Taavo	AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry )
Study ID Numbers:	D0850C00011, EudractCT 2007-006683-29
Study First Received:	May 16, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00681746
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Anxiety
GABA receptors
Positron Emission Tomography
PET
phase I

Study placed in the following topic categories:

Flumazenil
Healthy

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs

GABA Agents
Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on January 14, 2009