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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: OPC-34712 (4mg); Drug: Placebo; Drug: OPC-34712 (12mg); Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423916

331-10-242

Details and patient eligibility

About

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

Enrollment: 218 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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218 participants in 4 patient groups

Arm 1 (OPC-34712, placebo)

Active Comparator group

Description:

Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day.

Treatment:

Drug: Placebo

Drug: OPC-34712 (4mg)

Arm 2 (OPC-34712, placebo)

Active Comparator group

Description:

Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day.

Treatment:

Drug: Placebo

Drug: OPC-34712 (12mg)

Arm 3 (moxifloxacin, placebo)

Active Comparator group

Description:

Arm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days.

Treatment:

Drug: Placebo

Drug: Moxifloxacin

Arm 4 (moxifloxacin, placebo)

Active Comparator group

Description:

Arm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day.

Treatment:

Drug: Placebo

Drug: Moxifloxacin