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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00832221
First received: January 29, 2009
Last updated: September 11, 2009
Last verified: September 2009

January 29, 2009
September 11, 2009
January 2009
Not Provided
Positron emission tomography using the radioligand [11C]raclopride [ Time Frame: 5 visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832221 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of quetiapine and its main active metabolite [ Time Frame: 22 samples ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Depression
  • Drug: SEROQUEL XR (quetiapine)
    repeated dose of oral tablets, 8 times per subject
  • 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
  • Active Comparator: 1
    Interventions:
    • Drug: SEROQUEL XR (quetiapine)
    • Drug: radioligand [11C]raclopride
  • Active Comparator: 2
    Interventions:
    • Drug: SEROQUEL IR (quetiapine)
    • Drug: radioligand [11C]raclopride
Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D₂ dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2009
Not Provided

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00832221
D1443C00038, EudractCT 2008-006553-40
No
Märta Segerdahl, MD, PhD, Medical Science Director, Clinical Discovery Team, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Ingemar Bylesjö, MD, PhD AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Study Director: Sophia Bengtsson AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP