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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681720
First received: May 19, 2008
Last updated: August 20, 2008
Last verified: August 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

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

No publications provided

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
Study First Received: May 19, 2008
Last Updated: August 20, 2008
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on October 21, 2014