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.
This is an open-label, fixed sequence, multiple dose design. Following screening evaluations, subjects will check-in to the clinical research unit. After confirmation of continuation criteria, subjects will undergo an oral glucose tolerance test (oGTT), mixed meal tolerance test (MMTT) and spirulina breath test (GEBT). After these assessments are completed, subjects will have their prior antipsychotic (PA) or any other medication with psychotropic propensity washed out (dependent on their antipsychotic elimination half-life). Subjects will undergo SEP-363856 titration schedule, followed by the oGTT, MMTT and GEBT tests during the SEP-363856 Stable Dose Period. Subjects will be stabilized on their prior antipsychotic, discharged from the clinical research unit, and return to the unit for the follow-up visit 7 + 2 days after discharge.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Collaborative Neuroscience Research, LLC
Long Beach, California, United States
Catalina Research Institute LLC
Montclair, California, United States
CNRI - San Diego LLC
San Diego, California, United States
Galiz Research
Hialeah, Florida, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment.
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment.
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change from baseline (PA) in plasma AUC0-240 min and Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment.
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change in kPCD, baseline to stable dose (SEP-363856) period assessment
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points.
Visual Analog Scale (VAS) is on a scale of 0-100, higher represents higher pain intensity (higher score represents worse outcome).
Time frame: PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Change in lag time, baseline to stable dose (SEP-363856) period assessment
Time frame: PA Baseline and SEP-363856 Stalbe Dose Period (up to 48 days)
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