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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832221

Acronym

PET

Enrollment

Registered

2009-01-30

Start date

2009-01-31

Completion date

2009-09-30

Last updated

2009-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

PET, Phase 1, Depression, SEROQUEL, Positron Emission Tomography, Drug profile comparison

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.

Interventions

DRUGSEROQUEL XR (quetiapine)

repeated dose of oral tablets, 8 times per subject

DRUGSEROQUEL IR (quetiapine)

repeated dose of oral tablets, 4 times per subject

DRUGradioligand [11C]raclopride

single dose of iv admin, 5 times per subject

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026