MedTrace Logo

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

NCT01568203 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-10-10

No results posted yet for this study

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).

Conditions

Interventions

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)

DRUG

Placebo

Matching placebo control for AMG 579 at each dose level

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568203 on ClinicalTrials.gov