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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.

• Body mass index of 19 to 35 kg/m2.

Exclusion Criteria:

• Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.

• Subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator.

• Subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout.

• Subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.

• Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.

• Hospitalization for an exacerbation of schizophrenia or schizoaffective disorder within 3 months prior to randomization.

• Subjects who have a history of or who have evidence of other medical and/or neurological conditions that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial.

• Subjects with a history of neuroleptic malignant syndrome.

• Subjects with a history of seizure disorder.

• Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to randomization.