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

NCT ID: NCT00892944

Last Updated: 2009-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD2516

Group Type EXPERIMENTAL

AZD2516

Intervention Type DRUG

Fractionated single oral dose

Interventions

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AZD2516

Fractionated single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ingemar Bylesjo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden

Michael O'Malley

Role: STUDY_DIRECTOR

AstraZeneca R&D, Södertälje, Sweden

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D2080C00009

Identifier Type: -

Identifier Source: org_study_id

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