Phase 1
Completed N=218
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Source: ClinicalTrials.gov NCT01423916 ↗Enrolled (actual)
218
Serious AEs
0.4%
Results posted
Oct 2015
Primary outcomePrimary: Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment. — 9.2; -0.2; 2.6; 9.4 msec
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment. |
9.2; -0.2; 2.6; 9.4; -0.2; 1.2 | — |
| PRIMARY Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram). |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin. |
170; 462; 2760 | — |
| PRIMARY Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin. |
3.54; 3.00; 1.25 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve During Dosing (AUCT). |
3100; 8880; 28400 | — |
| SECONDARY Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11. |
5; 4; 5; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline). |
11.6; 12.4; 10.6; -1.1 | — |
| SECONDARY Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline). |
0.4; 0.9; 0.0; -1.2 | — |
| SECONDARY Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11. |
4; 1; 11; 2 | — |
| SECONDARY Number of Participants With QTcI Interval > 60 Msec on Day 11. |
0; 0; 0; 0 | — |
| SECONDARY Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11. |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11. |
0; 0; 0; 0; 4; 7 | — |
| SECONDARY Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval. |
0; 0; 0; 0; 5; 7 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01423916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.