Clinical trial NCT05402111: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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)
* 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.

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.

Primary outcomes:
measure: Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging)
timeFrame: multiple time-points post-radiolabelled meal on dosing day 1 and 2
measure: Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
timeFrame: 4 hours post-radiolabel meal on dosing Day 1 and 2
Secondary outcomes:
measure: Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal
timeFrame: 1 and 2 hours post-radiolabel meal
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America
state: Florida
city: Richardson
country: United States
facility: Pillar Clinical Research LLC
state: Texas
Study officials:
References: