The purpose of this study is to assess the safety and tolerability of AMG 579 following a single oral dose administration in healthy subjects (Part A) and in patients with schizophrenia or stable schizoaffective disorder (Part B). The study in healthy subjects (Part A) concluded, and following a protocol amendment, enrolled only patients with schizophrenia or stable schizoaffective disorder (Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
50
Research Site
Glendale, California, United States
Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs
Time frame: Up to 15 days
Incidence of treatment-emergent suicidal ideation and behavior
Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 15 days
Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579
Time frame: Up to 15 days
Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579
Time frame: Up to 15 days
Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579
Time frame: Up to 15 days
Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579
Time frame: Up to 15 days
Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)
Time frame: Up to 15 days
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