Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL (PET)

September 11, 2009 updated by: AstraZeneca

An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers

The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Normal MRI scan
  • Body mass index 19-30 kg/m2 and weight of 50-100 kg
  • Clinically normal physical findings, medical history and laboratory values

Exclusion Criteria:

  • Trauma or sickness last 2 weeks before the first PET examination.
  • A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
  • Any previous participation in a PET study
  • Subjects suffer from claustrophobia

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: radioligand [11C]raclopride
single dose of iv admin, 5 times per subject
Drug: SEROQUEL IR (quetiapine)
repeated dose of oral tablets, 4 times per subject
Active Comparator: 1
Drug: SEROQUEL XR (quetiapine)
repeated dose of oral tablets, 8 times per subject
Drug: radioligand [11C]raclopride
single dose of iv admin, 5 times per subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positron emission tomography using the radioligand [11C]raclopride
Time Frame: 5 visits
5 visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.
Time Frame: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.
5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.
Pharmacokinetics of quetiapine and its main active metabolite
Time Frame: 22 samples
22 samples

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: Sophia Bengtsson, AstraZeneca R&D, Södertälje, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2009

Last Update Submitted That Met QC Criteria

September 11, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443C00038
  • EudractCT 2008-006553-40

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.

Subscribe