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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

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

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Ingemar Bylesjö, MD, PhD, Principal Investigator, Affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Sophia Bengtsson, Study Director, Affiliation: AstraZeneca R&D, Södertälje, Sweden

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Positron emission tomography using the radioligand [11C]raclopride

Secondary outcome:

Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.

Pharmacokinetics of quetiapine and its main active metabolite

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Research Site, Stockholm, Sweden
Additional Information

Starting date: January 2009
Last updated: September 11, 2009

Page last updated: August 23, 2015

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