Positron emission tomography (PET) study with [11C]raclopride to determine central D2 dopamine occupancy of SEROQUEL - PET
Study identifier:D1443C00038
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Depression
Phase
Phase 1
Healthy volunteers
Yes
Study drug
SEROQUEL XR (quetiapine), SEROQUEL IR (quetiapine), radioligand [11C]raclopride
Sex
Male
Actual Enrollment
10
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jan 2009
Primary Completion Date: -
Study Completion Date: 01 Sept 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Ingemar Bylesjö
AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
