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 | Completed Phase 1 FDA Drug

• 1 other identifier: SEP361-124
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

Brief 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

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal

  1 and 2 hours post-radiolabel meal

Study Arms (2)

SEP-363856

EXPERIMENTAL

Drug: SEP-363856

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

ACTIVE COMPARATOR

Drug: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Interventions

SEP-363856 DRUG

SEP-363856 will be supplied by 25 mg and 50 mg tablets. Multiple tablets may be required to achieve a single dose.

SEP-363856

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) DRUG

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.

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (7)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

CNRI - San Diego, LLC

San Diego, California, 92102, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Research Centers of America

Oakland Park, Florida, 33334, United States

Location

Pillar Clinical Research LLC

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856; Risperidone; Olanzapine; Quetiapine Fumarate; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 2, 2022
• Study Start: June 13, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (7)