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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
SEP-363856 will be supplied by 25 mg and 50 mg tablets. Multiple tablets may be required to achieve a single dose.
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.
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Collaborative Neuroscience Research, LLC
Long Beach, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
Galiz Research
Hialeah, Florida, United States
Research Centers of America
Oakland Park, Florida, United States
Pillar Clinical Research LLC
Richardson, Texas, United States
Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging)
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.
Time frame: multiple time-points post-radiolabelled meal on dosing day 1 and 2
Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
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.
Time frame: 4 hours post-radiolabel meal on dosing Day 1 and 2
Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal
Gastric retention (proportion retained or % retained) at 1h and 2h post meal.
Time frame: 1 and 2 hours post-radiolabel meal
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