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An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00892944
First Posted: May 5, 2009
Last Update Posted: October 28, 2009
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 purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.

Condition Intervention Phase
Healthy Drug: AZD2516 Phase 1

Study Type: Interventional
Study Design: 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]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy [ Time Frame: 1 Month: Baseline and 3 PET examinations ]

Secondary Outcome Measures:
  • Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables [ Time Frame: Assessed at each visit from baseline to follow-up visit ]
  • To investigate the Pharmacokinetics of AZD2516 [ Time Frame: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose ]

Estimated Enrollment: 6
Study Start Date: April 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1
AZD2516
Drug: AZD2516
Fractionated single oral dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal MRI scan
  • Healthy male or non-fertile females
  • Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

  • History of disease or condition that may interfere with the objectives of the study
  • History of previous or ongoing psychiatric disease/condition
  • Concomitant medication
  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): NCT00892944


Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ingemar Bylesjo, MD, PhD AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Michael O'Malley AstraZeneca R&D, Södertälje, Sweden
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00892944     History of Changes
Other Study ID Numbers: D2080C00009
First Submitted: April 28, 2009
First Posted: May 5, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009

Keywords provided by AstraZeneca:
Positron Emission Tomography
Phase 1
Healthy volunteers
AZD2516