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-363856 May Have on Blood Sugar Levels After a Meal

Sponsor

Sunovion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05402111

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SEP-363856 Drug: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 13, 2022

Anticipated Primary Completion Date :

Jul 13, 2023

Anticipated Study Completion Date :

Jul 13, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) [multiple time-points post-radiolabelled meal on dosing day 1 and 2]
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.
Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging) [4 hours post-radiolabel meal on dosing Day 1 and 2]
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.

Secondary Outcome Measures

Gastric retention at 2 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging) [2 hours post-radiolabel meal on dosing Day 1 and 2]
Gastric retention at 2h post meal, estimates a percentage of gastric solids remaining in the stomach 2 hours after the meal.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group	Little Rock	Arkansas	United States	72211
2	Collaborative Neuroscience Research, LLC	Long Beach	California	United States	90806
3	CNRI - San Diego, LLC	San Diego	California	United States	92102
4	Pillar Clinical Research LLC	Richardson	Texas	United States	75080