Schizophrenia Clinical Trial
Official title:
An Open-Label, Positron Emission Tomography (PET) Study to Evaluate the Brain 5 HT6 Receptor Occupancy by Single Doses of SLV354 in Healthy Male Subjects and Subjects With Stable Schizophrenia
This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor occupancy in the brain using positron emission tomography (PET) following single oral doses of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia, between 18-55 years of age are to complete the study.
This is an exploratory, open-label PET study designed to examine the relationship between
SLV354 plasma concentration and 5-HT6 receptor occupancy in the brain following single oral
doses of SLV354 in healthy male subjects and male subjects with stable schizophrenia. A
total of up to 22 subjects are to complete the study, including approximately 12 subjects
with schizophrenia on a stable dose of an atypical antipsychotic medication. Within 60 days
prior to the PET scan, subjects will be screened based on medical history, physical
examination, vital signs, ECG, clinical laboratory tests, response to
Columbia-Suicide-Severity Rating Scale (C-SSRS) and for schizophrenia subjects only, the
diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental
Disorders-Fourth Edition-Text Revision (DSM-IV-TR). Following Screening, eligible subjects
will have a Magnetic Resonance Imaging (MRI) scan, unless one was performed within one year
of the PET scan, to delineate the region of interest for the individual PET images. The
radiotracer [11C]-QUICS will be used for the PET scans.
All subjects will receive a single oral dose of SLV354. Healthy subjects will have one PET
scan prior to and two PET scans after administration of SLV354. Schizophrenia subjects will
have two PET scans prior to and one PET scan after administration of SLV354.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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