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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00832221

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 I

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

Drug Information available for: Dopamine Dopamine hydrochloride Raclopride Quetiapine Quetiapine fumarate

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):

Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D? dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. Epub 2011 Apr 11.

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
Dopamine
Raclopride
Quetiapine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on February 09, 2012