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NCT01423916 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
A Phase 1 study of Schizophrenia and Schizoaffective Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 218
- Enrollment target
- 8
- Study locations
NCT01423916: Completed Phase 1 study of Schizophrenia and Schizoaffective Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01423916 is a Phase 1 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 218 participants, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target. The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01423916, a Phase 1 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 218 participants
- Enrollment target
- 8
- Study locations
Study 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
Primary Outcome
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG OPC-34712 (4mg)
- DRUG OPC-34712 (12mg)
Study Locations (8)
California
- Otsuka Investigational Site - Long Beach
- Otsuka Investigational Site - San Diego
Florida
- Otsuka Investigational Site - Fort Lauderdale
Kansas
- Otsuka Investigational Site - Overland Park
Maryland
- Otsuka Investigational Site - Rockville
Missouri
- Otsuka Investigational Site - St Louis
Pennsylvania
- Otsuka Investigational Site - Philadelphia
Texas
- Otsuka Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01423916 record still lists
NCT01423916 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01423916 lists 8 locations in 7 states (California, Florida, Kansas).
Frequently Asked Questions
What is clinical trial NCT01423916 about?
NCT01423916 is a clinical study titled "Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder". 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 (Q...
What is the current status of trial NCT01423916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2011-07. Estimated completion is 2012-03.
What conditions does trial NCT01423916 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT01423916?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), OPC-34712 (4mg) (DRUG), OPC-34712 (12mg) (DRUG).
Who is sponsoring clinical trial NCT01423916?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01423916 being conducted?
This trial has 8 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01423916's enrollment target sits among peer trials
218 83rd of 315 higher than 233 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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