A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With 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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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|
- Brain receptor occupancy [ Time Frame: Study Day -1 ] [ Designated as safety issue: No ]5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy
- Brain receptor occupancy [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy
- Pharmacokinetic profile [ Time Frame: Up through Study Day 4 ] [ Designated as safety issue: No ]Maximum observed plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-life (t1/2), oral plasma clearance (CL/F)
|Study Start Date:||May 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Group 1 (healthy), Group 2 (schizophrenia)||
One dose of ABT-354
Other Name: ABT-354
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545310
|United States, Connecticut|
|Site Reference ID/Investigator# 52162|
|New Haven, Connecticut, United States, 06520-8048|
|Study Director:||Earle Bain, MD||Abbott|