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

NCT ID: NCT01568203

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Schizophrenia

Keywords

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single dose, safety, healthy subjects, schizoaffective disorder, AMG 579

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AMG 579

Group Type EXPERIMENTAL

AMG 579

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo control for AMG 579 at each dose level

Interventions

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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)

Intervention Type DRUG

Placebo

Matching placebo control for AMG 579 at each dose level

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Glendale, California, United States

Site Status

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101275

Identifier Type: -

Identifier Source: org_study_id