Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
PET
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
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 depression
Started Jan 2009
Shorter than P25 for phase_1 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedSeptember 14, 2009
September 1, 2009
January 29, 2009
September 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positron emission tomography using the radioligand [11C]raclopride
5 visits
Secondary Outcomes (2)
Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.
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
22 samples
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Stockholm, Sweden
Related Publications (1)
Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D(2) 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. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11.
PMID: 21477416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingemar Bylesjö, MD, PhD
AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
- STUDY DIRECTOR
Sophia Bengtsson
AstraZeneca R&D, Södertälje, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
January 1, 2009
Study Completion
September 1, 2009
Last Updated
September 14, 2009
Record last verified: 2009-09