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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott

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.