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

Depression Clinical Trial

— PET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832221
• Other study ID #: D1443C00038
• Secondary ID: EudractCT 2008-0
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: September 11, 2009
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• SEROQUEL XR (quetiapine)
repeated dose of oral tablets, 8 times per subject
• SEROQUEL IR (quetiapine)
repeated dose of oral tablets, 4 times per subject
• radioligand [11C]raclopride
single dose of iv admin, 5 times per subject

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography using the radioligand [11C]raclopride		5 visits	No
Secondary	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.	Yes
Secondary	Pharmacokinetics of quetiapine and its main active metabolite		22 samples	No