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



Status:Completed
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:September 2011
End Date:February 2013
Contact:Amgen Call Center
Phone:866-572-6436

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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


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) has concluded. Following a recent protocol amendment, this study is now enrolling
only for patients with schizophrenia or stable schizoaffective disorder (Part B).


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 the same 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 or day -5 (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 listed
as enrollment has closed.
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