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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01568203
• Other study ID #: 20101275
• Status: Terminated
• Phase: Phase 1
• First received: February 27, 2012
• Last updated: October 5, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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
Matching placebo control for AMG 579 at each dose level

Locations

Country	Name	City	State
United States	Research Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs		Up to 15 days	Yes
Primary	Incidence of treatment-emergent suicidal ideation and behavior	Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 15 days	Yes
Secondary	Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579		Up to 15 days	No
Secondary	Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579		Up to 15 days	No
Secondary	Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579		Up to 15 days	No
Secondary	Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579		Up to 15 days	No
Secondary	Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)		Up to 15 days	Yes

External Links

•   AmgenTrials clinical trials website