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Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

NCT number NCT04865835
Study type Interventional
Source Sunovion
Contact CNS Medical Director
Phone 1-800-503-6351
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date May 10, 2021
Completion date July 19, 2021

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