Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01423916
First received: August 8, 2011
Last updated: April 9, 2012
Last verified: April 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: OPC-34712 (4mg) Drug: Moxifloxacin Drug: OPC-34712 (12mg) Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Change in time-matched QTcI [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Pharmacodynamics endpoint is the time-matched QTcI change from baseline (Day -1) corrected for placebo on Day 11 following OPC-34712 treatment.
- Change in plasma concentration [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax), time to maximum (peak) plasma concentration (tmax), and the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of OPC-34712 and moxifloxacin
Secondary Outcome Measures:
- Change in mean QTcI [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Time-matched change in mean QTcI change from baseline for assay sensitivity of moxifloxacin treatment corrected for placebo
- Change in maximum QTcI minus mean QTcI [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Maximum QTcI on Day 11 minus mean QTcI on Day -1 (baseline)
- Change in maximum QTcI minus maximum QTcI [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Maximum QTcI on Day 11 minus maximum QTcI on Day -1 (baseline)
- Incidence of maximum change in QTcI between 30 and 60 msec [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Incidence of maximum change from Day -1 (baseline) in QTcI interval between 30 and 60 msec on Day 11
- Incidence of maximum change in QTcI interval >60 msec [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Incidence of maximum change from Day -1 (baseline) in QTcI interval > 60 msec on Day 11
- New incidence of maximum QTcI interval >500 msec [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]New incidence of maximum QTcI interval > 500 msec on Day 11
- New incidence of maximum QT interval > 500 msec on Day 11 [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
- Change in ECG morphology [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
ECG morphology, reviewed by an experienced cardiologist, for new incidence of the following on Day 11:
U wave or appearance of abnormal U wave, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, left bundle branch block
- Maximum change in ECG values [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate, PR, QRS, and QT
| Enrollment: | 218 |
| Study Start Date: | July 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1 (OPC-34712, placebo)
Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day.
|
Drug: OPC-34712 (4mg)
Arms assigned to this intervention receive 4mg.
Drug: Placebo
OPC-34712 placebo
|
|
Active Comparator: Arm 2 (OPC-34712, placebo)
Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day.
|
Drug: OPC-34712 (12mg)
Arms assigned to this intervention receive 12mg.
Drug: Placebo
OPC-34712 placebo
|
|
Active Comparator: Arm 3 (moxifloxacin, placebo)
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.
|
Drug: Moxifloxacin
Arms assigned to this intervention will receive 400mg.
Drug: Placebo
OPC-34712 placebo
|
|
Active Comparator: Arm 4 (moxifloxacin, placebo)
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.
|
Drug: Moxifloxacin
Arms assigned to this intervention will receive 400mg.
Drug: Placebo
OPC-34712 placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423916
Locations
| United States, California | |
| Otsuka Investigational Site | |
| Long Beach, California, United States, 90806 | |
| Otsuka Investigational Site | |
| San Diego, California, United States, 92102 | |
| United States, Florida | |
| Otsuka Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Kansas | |
| Otsuka Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Maryland | |
| Otsuka Investigational Site | |
| Rockville, Maryland, United States, 20850 | |
| United States, Missouri | |
| Otsuka Investigational Site | |
| St. Louis, Missouri, United States, 63118 | |
| United States, Pennsylvania | |
| Otsuka Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Otsuka Investigational Site | |
| Austin, Texas, United States, 78754 | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT01423916 History of Changes |
| Other Study ID Numbers: | 331-10-242 |
| Study First Received: | August 8, 2011 |
| Last Updated: | April 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
Schizophrenia QTc Interval |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013