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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00892944
First received: April 28, 2009
Last updated: October 27, 2009
Last verified: October 2009
  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: 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]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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To investigate the Pharmacokinetics of AZD2516 [ Time Frame: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00892944     History of Changes
Other Study ID Numbers: D2080C00009
Study First Received: April 28, 2009
Last Updated: October 27, 2009
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on August 28, 2014