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

NCT01545310 | Completed Phase 1

• 1 other identifier: M12-700
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Brain receptor occupancy

  5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy

  Study Day -1

• Brain receptor occupancy

  5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy

  Study Day 1

Secondary Outcomes (1)

• Pharmacokinetic profile

  Up through Study Day 4

Study Arms (1)

Group 1 (healthy), Group 2 (schizophrenia)

EXPERIMENTAL

Drug: SLV354

Interventions

SLV354 DRUG

One dose of ABT-354

Also known as: ABT-354

Group 1 (healthy), Group 2 (schizophrenia)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, age between 18 and 55 years, inclusive.
• Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia).
• A condition of general good physical health.
• Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR).
• Schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to Screening.

You may not qualify if:

• Presence of a metal implant that would preclude a Magnetic Resonance Imaging (MRI) scan.
• Radiation exposure for research purposes within the past year that will exclude participation in the study.
• Significant current suicidal ideation within the past month as evidenced by Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening.
• History of psychiatric diseases or disorders (healthy subjects)
• Unsuitable to receive SLV354 or the radiotracer, \[11C\]-QUICS.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 52162

New Haven, Connecticut, 06520-8048, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Earle Bain, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: March 6, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

US (1)