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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681746
First Posted: May 21, 2008
Last Update Posted: December 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Positron emission tomography using the radioligand (11C) flumazenil [ Time Frame: 4 times per subject ]

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. ]
  • 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. ]

Estimated Enrollment: 8
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Mark A. Smith, MD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681746     History of Changes
Other Study ID Numbers: D0850C00011
EudractCT 2007-006683-29
First Submitted: May 16, 2008
First Posted: May 21, 2008
Last Update Posted: December 10, 2010
Last Verified: November 2008

Keywords provided by AstraZeneca:
Anxiety
GABA receptors
Positron Emission Tomography
PET
phase I

Additional relevant MeSH terms:
Flumazenil
Antidotes
Protective Agents
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action