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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-26

No results posted yet for this study

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

Interventions

DRUG

SEP-363856

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-08-22
Completion
2023-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463770 on ClinicalTrials.gov