Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: SEROQUEL XR (quetiapine) (Drug); SEROQUEL IR (quetiapine) (Drug); radioligand [11C]raclopride (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Ingemar Bylesjö, MD, PhD, Principal Investigator, Affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Sophia Bengtsson, Study Director, Affiliation: AstraZeneca R&D, Södertälje, Sweden
Overall contact:
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
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.
Clinical Details
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
Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Positron emission tomography using the radioligand [11C]raclopride
Secondary outcome: Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.Pharmacokinetics of quetiapine and its main active metabolite
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Research Site, Stockholm, Sweden; Recruiting
Additional Information
Starting date: January 2009
Ending date: June 2009
Last updated: January 29, 2009
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