First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia

Phase 1

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: AMG 579; Drug: Placebo

• Registration Number: NCT01568203
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 579	AMG 579	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) 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
Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579	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
Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)	Up to 15 days

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States