Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination