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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: SEROQUEL XR (quetiapine)
* Drug: SEROQUEL IR (quetiapine)
* Drug: radioligand [11C]raclopride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: SEROQUEL XR (quetiapine)<br>* repeated dose of oral tablets, 8 times per subject<br>Drug: radioligand [11C]raclopride<br>* single dose of iv admin, 5 times per subject<br>|
| Active Comparator: 2<br> | Drug: SEROQUEL IR (quetiapine)<br>* repeated dose of oral tablets, 4 times per subject<br>Drug: radioligand [11C]raclopride<br>* single dose of iv admin, 5 times per subject<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography using the radioligand [11C]raclopride |  | 5 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, Phase 1, Depression, SEROQUEL, Positron Emission Tomography, Drug profile comparison