Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Public ClinicalTrials.gov record NCT01423916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01423916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 218 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2011
- Primary completion
- Jan 31, 2012
- Completion
- Feb 29, 2012
- Last update posted
- Oct 28, 2015
2011 – 2012
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Otsuka Investigational Site | Long Beach | California | 90806 | — |
| Otsuka Investigational Site | San Diego | California | 92102 | — |
| Otsuka Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| Otsuka Investigational Site | Overland Park | Kansas | 66212 | — |
| Otsuka Investigational Site | Rockville | Maryland | 20850 | — |
| Otsuka Investigational Site | St Louis | Missouri | 63118 | — |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19139 | — |
| Otsuka Investigational Site | Austin | Texas | 78754 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01423916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2015 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01423916 live on ClinicalTrials.gov.