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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: SEROQUEL XR (quetiapine); Drug: radioligand [11C]raclopride; Drug: SEROQUEL IR (quetiapine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832221

EudractCT 2008-006553-40

D1443C00038

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: radioligand [11C]raclopride

Drug: SEROQUEL XR (quetiapine)

2

Active Comparator group

Treatment:

Drug: radioligand [11C]raclopride

Drug: SEROQUEL IR (quetiapine)