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”

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.

Study Type: Interventional

Study Design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: SEROQUEL XR (quetiapine)
  • repeated dose of oral tablets, 8 times per subject
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Positron emission tomography using the radioligand [11C]raclopride
  • Time Frame: 5 visits
    Safety Issue?: No

Secondary 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.
    Safety Issue?: Yes
• Pharmacokinetics of quetiapine and its main active metabolite
  • Time Frame: 22 samples
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Ingemar Bylesjö, MD, PhD Principal Investigator AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00832221

Study ID Number: D1443C00038

ClinicalTrials.gov Identifier: NCT00832221

Health Authority: Sweden: Medical Products Agency