NCT01423916

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

A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-08-26
• Last updated: 2015-10-29
• Results posted: 2015-10-29

Locations

8 sites across 1 country: United States