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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
April 28, 2009
May 5, 2009
October 28, 2009
April 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00892944 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: AZD2516
Fractionated single oral dose
Experimental: 1
AZD2516
Intervention: Drug: AZD2516
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2009
Not Provided

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
Sexes Eligible for Study: All
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00892944
D2080C00009
No
Not Provided
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Ingemar Bylesjo, MD, PhD AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Michael O'Malley AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP