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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00832221

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: SEROQUEL XR (quetiapine) Drug: SEROQUEL IR (quetiapine) Drug: radioligand [11C]raclopride	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Jan 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Drug: SEROQUEL XR (quetiapine)

repeated dose of oral tablets, 8 times per subject

Drug: radioligand [11C]raclopride

single dose of iv admin, 5 times per subject

Active Comparator: 2

Drug: SEROQUEL IR (quetiapine)

repeated dose of oral tablets, 4 times per subject

Drug: radioligand [11C]raclopride

single dose of iv admin, 5 times per subject

Outcome Measures

Primary Outcome Measures

Positron emission tomography using the radioligand [11C]raclopride [5 visits]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Stockholm		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Ingemar Bylesjö, MD, PhD, AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson, AstraZeneca R&D, Södertälje, Sweden