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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

SEROQUEL XR (quetiapine)

Intervention Type DRUG

repeated dose of oral tablets, 8 times per subject

radioligand [11C]raclopride

Intervention Type DRUG

single dose of iv admin, 5 times per subject

2

Group Type ACTIVE_COMPARATOR

SEROQUEL IR (quetiapine)

Intervention Type DRUG

repeated dose of oral tablets, 4 times per subject

radioligand [11C]raclopride

Intervention Type DRUG

single dose of iv admin, 5 times per subject

Interventions

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SEROQUEL XR (quetiapine)

repeated dose of oral tablets, 8 times per subject

Intervention Type DRUG

SEROQUEL IR (quetiapine)

repeated dose of oral tablets, 4 times per subject

Intervention Type DRUG

radioligand [11C]raclopride

single dose of iv admin, 5 times per subject

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes