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Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

NCT01423916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2015-10-29

Study results available
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Summary

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold:

* To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo
* To determine the effect of moxifloxacin on QTcI
* To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Conditions

Interventions

DRUG

OPC-34712 (4mg)

Arms assigned to this intervention receive 4mg.

DRUG

Moxifloxacin

Arms assigned to this intervention will receive 400mg.

DRUG

OPC-34712 (12mg)

Arms assigned to this intervention receive 12mg.

DRUG

Placebo

OPC-34712 placebo

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01423916 on ClinicalTrials.gov