First-in-Human Study to Evaluate AMG 579 in Healthy Subjects and Patients With Stable Schizophrenia
This study has been terminated.
(Amgen decision (business))
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01568203
First received: February 27, 2012
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: AMG 579 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Incidence of treatment-emergent suicidal ideation and behavior [ Time Frame: Up to 15 days ] [ Designated as safety issue: Yes ]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 Frame: Up to 15 days ] [ Designated as safety issue: No ]
- Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579 [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579 [ Time Frame: Up to 15 days ] [ Designated as safety issue: No ]
- Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS) [ Time Frame: Up to 15 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AMG 579 |
Drug: AMG 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)
|
| Placebo Comparator: Placebo |
Drug: Placebo
Matching placebo control for AMG 579 at each dose level
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01568203 History of Changes |
| Other Study ID Numbers: | 20101275 |
| Study First Received: | February 27, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
single dose, safety, healthy subjects, schizoaffective disorder, AMG 579 |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013