A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will be conducted in approximately 2 study sites in the United States.
This is a randomized, single-blind, two-period crossover study in which each subject will receive both treatments and therefore act as their own control to minimize confounding covariates within the study population. Randomizing subjects to treatment sequence will assist with reducing the potential order effects that might confound the findings if all the subjects received the same treatment sequence. The single-blind method is used to keep subjects blind to treatment assignment throughout the study period, in order to avoid possible influence of the psychological factors of subjects on study assessments. This clinical study will evaluate whether SEP 363856 influences the PK of a concomitantly administered OCT2 substrate, metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
single dose of placebo
single dose of SEP 363856 100 mg
metformin-HCl 850 mg
At Fort Lauderdale Behavioral Health Center
Oakland Park, Florida, United States
Hassman Research Institute
Marlton, New Jersey, United States
Area under the plasma concentration-time curve
area under the plasma concentration-time curve from time zero to infinity (AUC0 ∞) or area under the plasma concentration-time curve from time zero to a defined time (AUC0-t), if appropriate
Time frame: 72 hours
• maximum observed plasma concentration
maximum observed plasma concentration (Cmax).
Time frame: 72 hours
area under the plasma concentration-time curve
area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-last)
Time frame: 72 hours
time of the maximum observed plasma concentration
time of the maximum observed plasma concentration (tmax)
Time frame: 72 hours
time of last quantifiable concentration
time of last quantifiable concentration (Tlast)
Time frame: 72 hours
• percentage of extrapolated AUC0-∞
percentage of extrapolated AUC0-∞ (%AUCextrap)
Time frame: 72 hours
terminal elimination half-life
terminal elimination half-life(T1/2)
Time frame: 72 hours
apparent clearance
apparent clearance (CL/F)
Time frame: 72 hours
apparent volume of distribution
apparent volume of distribution (VZ/F)
Time frame: 72 hours
amount excreted in urine
amount excreted in urine (Ae)
Time frame: 72 hours
percentage excreted in urine
percentage excreted in urine (Fe)
Time frame: 72 hours
renal clearance
renal clearance (CLR)
Time frame: 72 hours
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