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Terminated/Withdrawn
Sponsor ID
20101275

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

Sponsor ID
20101275
Clinicaltrials.gov ID
NCT01568203
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 1
Product
AMG 579
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
50
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs

Timeframe: Up to 15 days

Incidence of treatment-emergent suicidal ideation and behavior

Timeframe: Up to 15 days

Secondary Outcome Measures

Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579

Timeframe: Up to 15 days

Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579

Timeframe: Up to 15 days

Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579

Timeframe: Up to 15 days

Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579

Timeframe: Up to 15 days

Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)

Timeframe: Up to 15 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Glendale, CA, United States, 91206
Status
Completed
Study Info
Age
18 - 60 Years
Condition
  • Schizophrenia
    • Sex
    All
    Trial Dates
    Sep 2011 - Jun 2012
    Inclusion and Exclusion 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.