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

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ClinicalTrials.gov Identifier: NCT01568203
Recruitment Status : Terminated (Amgen decision (business))
First Posted : April 2, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AMG 579 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
  2. Incidence of treatment-emergent suicidal ideation and behavior [ Time Frame: Up to 15 days ]
    Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)


Secondary Outcome Measures :
  1. Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579 [ Time Frame: Up to 15 days ]
  2. Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579 [ Time Frame: Up to 15 days ]
  3. 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 ]
  4. Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579 [ Time Frame: Up to 15 days ]
  5. Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS) [ Time Frame: Up to 15 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568203


Locations
United States, California
Research Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01568203     History of Changes
Other Study ID Numbers: 20101275
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Amgen:
single dose, safety, healthy subjects, schizoaffective disorder, AMG 579

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders