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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01545310
First received: December 15, 2011
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: SLV354
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 18
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (healthy), Group 2 (schizophrenia) Drug: SLV354
One dose of ABT-354
Other Name: ABT-354

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545310

Locations
United States, Connecticut
Site Reference ID/Investigator# 52162
New Haven, Connecticut, United States, 06520-8048
Sponsors and Collaborators
Abbott
Investigators
Study Director: Earle Bain, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01545310     History of Changes
Other Study ID Numbers: M12-700
Study First Received: December 15, 2011
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014