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COMPLETED 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

NCT05402111 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05402111

The ClinicalTrials.gov registry entry for NCT05402111 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05402111 reports 7 study locations spanning 4 distinct geographic areas — top geographies include Arkansas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05402111?

The interventions under investigation include: SEP-363856 (DRUG), Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05402111?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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