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

October 27, 2009 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD2516
Drug: AZD2516
Fractionated single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 Month: Baseline and 3 PET examinations

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Ingemar Bylesjo, MD, PhD, Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
  • Study Director: Michael O'Malley, AstraZeneca R&D, Södertälje, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D2080C00009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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