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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681746
First received: May 16, 2008
Last updated: December 8, 2010
Last verified: November 2008
  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
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 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 ] [ 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: 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

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
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, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: May 16, 2008
Last Updated: December 8, 2010
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on August 20, 2014