Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
Phase 1
Completed
- Conditions
- Depression
- Interventions
- Registration Number
- NCT00832221
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 radioligand [11C]raclopride - 2 SEROQUEL IR (quetiapine) - 2 radioligand [11C]raclopride - 1 SEROQUEL XR (quetiapine) -
- Primary Outcome Measures
Name Time Method Positron emission tomography using the radioligand [11C]raclopride 5 visits
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇸🇪Stockholm, Sweden