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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832221
First Posted: January 30, 2009
Last Update Posted: September 14, 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
  Purpose
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.

Condition Intervention Phase
Depression Drug: SEROQUEL XR (quetiapine) Drug: SEROQUEL IR (quetiapine) Drug: radioligand [11C]raclopride Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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. ]
  • Pharmacokinetics of quetiapine and its main active metabolite [ Time Frame: 22 samples ]

Estimated Enrollment: 10
Study Start Date: January 2009
Study Completion Date: September 2009
Arms Assigned Interventions
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
Active Comparator: 2 Drug: SEROQUEL IR (quetiapine)
repeated dose of oral tablets, 4 times per subject
Drug: radioligand [11C]raclopride
single dose of iv admin, 5 times per subject

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832221


Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ingemar Bylesjö, MD, PhD AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson AstraZeneca R&D, Södertälje, Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Märta Segerdahl, MD, PhD, Medical Science Director, Clinical Discovery Team, AstraZeneca
ClinicalTrials.gov Identifier: NCT00832221     History of Changes
Other Study ID Numbers: D1443C00038
EudractCT 2008-006553-40
First Submitted: January 29, 2009
First Posted: January 30, 2009
Last Update Posted: September 14, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
PET
Phase 1
Depression
SEROQUEL
Positron Emission Tomography
Drug profile comparison

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Quetiapine Fumarate
Raclopride
Dopamine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dopamine Antagonists


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