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 Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SEP-363856; Drug: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Detailed Description

This is a randomized, open-label, single dose two-period crossover study with two treatment sequences. For each treatment sequence, subjects will receive a single-dose of SEP-363856 and prior antipsychotic (PA) standard of care (PA) in random order. Up to 3 separate cohorts of subjects will be randomized to determine the final dose of SEP-363856.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest, LLC
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Research, LLC
    • San Diego, California, United States, 92102
      • CNRI - San Diego, LLC
  • Florida
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America
  • Texas
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: (this list is not all inclusive)

• Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
• Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT]).
• Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
• Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
• Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.

Exclusion Criteria: (this list is not all inclusive)

• Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ < 70).

  • Subject has attempted suicide within 12 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
  • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEP-363856	Drug: SEP-363856; SEP-363856 will be supplied by 25 mg and 50 mg tablets. Multiple tablets may be required to achieve a single dose.
Active Comparator: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)	Drug: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole); PA will be prepared by the pharmacy staff according to the patient's prescribed treatment and will be orally administered. Multiple tablets or capsules may be required to achieve a single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging)	Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) is gastric emptying half life (T1/2), which is a time needed for the half of the ingested gastric solids to leave the stomach.	multiple time-points post-radiolabelled meal on dosing day 1 and 2
Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)	Gastric retention at 4 hr post-radiolabeled meal is gastric retention 4h post meal, which estimates a percentage of remaining gastric solids in the stomach 4 hours after the meal.	4 hours post-radiolabel meal on dosing Day 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal	Gastric retention (proportion retained or % retained) at 1h and 2h post meal.	1 and 2 hours post-radiolabel meal

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Study Director: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Selective Serotonin Reuptake Inhibitors; Olanzapine; Aripiprazole; Quetiapine Fumarate; Risperidone; Antipsychotic Agents
• Other Study ID Numbers: SEP361-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No