A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: SLV354

• Registration Number: NCT01545310
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1 (healthy), Group 2 (schizophrenia)	SLV354	-

Primary Outcome Measures

Name	Time	Method
Brain receptor occupancy	Study Day 1	5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile	Up through Study Day 4	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)

Trial Locations

Locations (1)

Site Reference ID/Investigator# 52162; 🇺🇸 New Haven, Connecticut, United States