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Completed

NCT Number: NCT00832221

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

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEROQUEL XR (quetiapine)

Drug

repeated dose of oral tablets, 8 times per subject

SEROQUEL IR (quetiapine)

Drug

repeated dose of oral tablets, 4 times per subject

radioligand [11C]raclopride

Drug

single dose of iv admin, 5 times per subject

Primary outcomes

  1. Positron emission tomography using the radioligand [11C]raclopride

    Time frame: 5 visits

Secondary outcomes

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

    Time frame: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.

  2. Pharmacokinetics of quetiapine and its main active metabolite

    Time frame: 22 samples

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: PET

Important dates

Study start
2009
Study completion
2009
First posted
Jan 30, 2009
Registry last updated
Sep 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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