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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681720
First Posted: May 21, 2008
Last Update Posted: August 21, 2008
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 AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.

Condition Intervention Phase
Anxiety Drug: AZD7325 Drug: Radioligand (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 AZD7325 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, physical examination, psychometric tests and laboratory variables. [ Time Frame: 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 ]
  • Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma [ Time Frame: 3 times per subject. Up to 48 hours each time. ]

Enrollment: 4
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD7325
Single dose of oral solution or capsule. 3 times per subject.
Drug: Radioligand (11C) flumazenil
Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)

  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.
  • 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.
  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): NCT00681720


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
ClinicalTrials.gov Identifier: NCT00681720     History of Changes
Other Study ID Numbers: D1140C00007
EudractCT 2007-005436-86
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: August 21, 2008
Last Verified: August 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