Schizophrenia
Conditions
Keywords
single dose, safety, healthy subjects, schizoaffective disorder, AMG 579
Brief summary
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).
Interventions
DRUGAMG 579
3 dose levels of single oral dose administration of AMG 579 in healthy subjects (Part A), and 5 dose levels of single oral dose administration of AMG 579 in patients with schizophrenia or schizoaffective disorder (Part B)
DRUGPlacebo
Matching placebo control for AMG 579 at each dose level
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia (chronic, all types) or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) criteria and by Mini International Neuropsychiatric Interview (M.I.N.I.) 6.0 for Schizophrenia and Psychotic Disorders Studies * Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 38.0 kg/m2, inclusive, at screening * Patient is judged by the Investigator to be likely to tolerate being off of antipsychotic medications for the duration of the trial (for patients withdrawing from or currently not taking antipsychotic medications) * Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks within enrollment. If patient is on antipsychotic medications, they must be on second generation oral antipsychotic therapy (eg, ziprasidone, quetiapine, olanzapine, etc) for at least 8 weeks within enrollment and at least one month within enrollment on a stable dose
Exclusion criteria
* Hospitalized for psychiatric symptoms in the 3 months within enrollment * Patients with evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70 * Current risk of self-harm or violence as determined by the investigator, or current risk of suicide or history of suicidal behavior within 12 months of enrollment, and/or ongoing suicidal ideation as assessed using Columbia-Suicidal Severity Rating Scale (C-SSRS) at screening (eg, any response of yes to the Suicidal Ideation questions on the C-SSRS in the past 12 months). Additional critera apply. Eligibility criteria for healthy subjects (Part A) not outlined above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs | Up to 15 days | — |
| Incidence of treatment-emergent suicidal ideation and behavior | Up to 15 days | Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579 | Up to 15 days |
| Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579 | Up to 15 days |
| Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS) | Up to 15 days |
| Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579 | Up to 15 days |
| Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579 | Up to 15 days |
Countries
United States
Outcome results
None listed