A Clinical Study to Determine Whether an Investigational Medication (SEP-363856) Changes How Long it Takes for Food to Move Through the Stomach Into the Small Intestine in Patients With Schizophrenia. The Study Will Help to Understand Any Effect SEP

• Status: Not yet recruiting
• Trial end date: 2023-07-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Quetiapine Fumarate; Risperidone

Criteria

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)

• Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.

• 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.

• Subject's BMI must be ≥ 30 kg/m2 at Screening and Check-in.

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.

• Subject has a disorder or history of a condition, or previous gastrointestinal conditions that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic or renal system, or a history of malabsorption, or a history of bowel resection or history of bariatric surgery or being on medications that might interfere with gastric motility.

• Subject has used any prescription medications or herbal supplements affecting GI motility, glucose homeostasis (such as immunosuppressants, testosterone, GH, etc) or weight (loss or gain) within 3 months prior to Day 1 or anticipates the need for any outlined disallowed medication classes during their participation in this study. Subject has used other prescription non-psychotropic or over the counter (OTC) medications, including herbal supplements or Metabolife 14 days or 5 half-lives (whichever is longer) prior to Day -1