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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545310
• Other study ID #: M12-700
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2011
• Last updated: September 14, 2012
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

1. Male, age between 18 and 55 years, inclusive.

2. Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia).

3. A condition of general good physical health.

4. Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR).

5. Schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to Screening.

Exclusion Criteria

1. Presence of a metal implant that would preclude a Magnetic Resonance Imaging (MRI) scan.

2. Radiation exposure for research purposes within the past year that will exclude participation in the study.

3. Significant current suicidal ideation within the past month as evidenced by Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening.

4. History of psychiatric diseases or disorders (healthy subjects)

5. Unsuitable to receive SLV354 or the radiotracer, [11C]-QUICS.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SLV354
One dose of ABT-354

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 52162	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain receptor occupancy	5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy	Study Day -1	No
Primary	Brain receptor occupancy	5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy	Study Day 1	No
Secondary	Pharmacokinetic profile	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)	Up through Study Day 4	No