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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00832221
First received: January 29, 2009
Last updated: September 11, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Positron emission tomography using the radioligand [11C]raclopride [ Time Frame: 5 visits ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of quetiapine and its main active metabolite [ Time Frame: 22 samples ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: January 29, 2009
Last Updated: September 11, 2009
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Raclopride
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013