A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

NCT05463770 | Completed Phase 1 FDA Drug

• 1 other identifier: SEP361-123
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes:

• how the body processes (uses) glucose (blood sugar)
• how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body. The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose. This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (2)

• Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

• Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

Secondary Outcomes (6)

• Change from baseline (PA) in plasma AUC0-240 min and Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

• Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

• Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

• Change in kPCD, baseline to stable dose (SEP-363856) period assessment

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

• Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points.

  PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)

Study Arms (1)

SEP-363856

EXPERIMENTAL

Drug: SEP-363856

Interventions

SEP-363856 DRUG

SEP-363856, 12.5 mg, 25 mg, and 50 mg tablets. The dose taken at the same time each day, in the evening and in the morning. Multiple tablets may be required to achieve a single dose.

SEP-363856

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 (8)

Woodland International Research Group, LLC

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

Catalina Research Institute LLC

Montclair, California, 91763, United States

Location

CNRI - San Diego LLC

San Diego, California, 92102, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

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

Model Details: This is an open-label, fixed sequence, multiple dose design.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 19, 2022
• Study Start: August 30, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 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: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (8)