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

Sponsored by:	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:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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
2: Active Comparator	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

Contacts

Contact: AstraZeneca Clinical Study Information

1-800-236-9933

information.center@astrazeneca.com

Locations

Sweden
Research Site	Recruiting
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

Responsible Party:	AstraZeneca ( Märta Segerdahl, MD, PhD, Medical Science Director, Clinical Discovery Team )
Study ID Numbers:	D1443C00038, EudractCT 2008-006553-40
Study First Received:	January 29, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00832221 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

PET
Phase 1
Depression

SEROQUEL
Positron Emission Tomography
Drug profile comparison

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Healthy
Depressive Disorder
Antipsychotic Agents

Behavioral Symptoms
Quetiapine
Dopamine
Mental Disorders
Raclopride
Mood Disorders
Dopamine Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Depression
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Mental Disorders
Therapeutic Uses
Raclopride
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2009