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NCT05402111 · ClinicalTrials.gov registry record · Phase 1

A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard

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

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
7
Study locations

NCT05402111 is a Phase 1 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 31 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The trial reports 7 study locations across 4 states.

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The verdict

NCT05402111, a Phase 1 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target
7
Study locations

Study Summary

A clinical study to determine whether an investigational medication (SEP363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. This study is accepting both male and female subjects. It will be conducted in approximately 6 study sites in the United States. The duration of participation will be approximtely 10 weeks.

Conditions Studied

Interventions

  • DRUG SEP-363856
  • DRUG Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Study Locations (7)

Arkansas

  • Woodland International Research Group - Little Rock
  • Woodland Research Northwest, LLC - Rogers

California

  • Collaborative Neuroscience Research, LLC - Long Beach
  • CNRI - San Diego, LLC - San Diego

Florida

  • Galiz Research - Hialeah
  • Research Centers of America - Oakland Park

Texas

  • Pillar Clinical Research LLC - Richardson

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2022-06-13
Est. Completion 2023-09-27
Phase Phase 1

What the Registry Record Tells You About NCT05402111

The ClinicalTrials.gov registry entry for NCT05402111 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which SEP-363856 is the first listed.

NCT05402111 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Arkansas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05402111 about?

NCT05402111 is a clinical study titled "A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard". A clinical study to determine whether an investigational medication (SEP363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. This study is accepting both male and female subjects. It will be conducted in approximately 6 study...

What is the current status of trial NCT05402111?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-06-13. Estimated completion is 2023-09-27.

What conditions does trial NCT05402111 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT05402111?

The interventions under investigation include: SEP-363856 (DRUG), Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) (DRUG).

Who is sponsoring clinical trial NCT05402111?

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

Where is trial NCT05402111 being conducted?

This trial has 7 study locations across Arkansas, California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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