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NCT04369391 · ClinicalTrials.gov registry record · Phase 1

A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
150
Enrollment target

NCT04369391: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT04369391 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 150 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04369391, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
150 participants
Enrollment target

Study Summary

A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 7 locations in the US. The study will last approximately 7 weeks.

Interventions

  • DRUG Placebo
  • DRUG moxifloxacin 400 mg
  • DRUG SEP363856 150 mg

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2020-06-18
Est. Completion 2020-11-10
Phase Phase 1

What the finished NCT04369391 record still lists

NCT04369391 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04369391 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04369391 about?

NCT04369391 is a clinical study titled "A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.". A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizoph...

What is the current status of trial NCT04369391?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2020-06-18. Estimated completion is 2020-11-10.

What interventions are being tested in trial NCT04369391?

The interventions under investigation include: Placebo (DRUG), moxifloxacin 400 mg (DRUG), SEP363856 150 mg (DRUG).

Who is sponsoring clinical trial NCT04369391?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04369391's enrollment target sits among peer trials

150 363rd of 2000 higher than 1,620 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04369391, the US trial registry maintained by the National Library of Medicine. NCT04369391 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.