First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 579
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring single dose, safety, healthy subjects, schizoaffective disorder, AMG 579
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 579
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs
Incidence of treatment-emergent suicidal ideation and behavior
Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Secondary Outcome Measures
Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579
Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579
Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579
Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579
Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568203
Brief Title
First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia
Official Title
Phase I, Randomized, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 579 in Healthy Adult Subjects and Patients With Stable Schizophrenia or Schizoaffective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Amgen decision (business)
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
single dose, safety, healthy subjects, schizoaffective disorder, AMG 579
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 579
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 579
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo control for AMG 579 at each dose level
Primary Outcome Measure Information:
Title
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
Title
Incidence of treatment-emergent suicidal ideation and behavior
Description
Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Up to 15 days
Secondary Outcome Measure Information:
Title
Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579
Time Frame
Up to 15 days
Title
Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579
Time Frame
Up to 15 days
Title
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
Title
Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579
Time Frame
Up to 15 days
Title
Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)
Time Frame
Up to 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia
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