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.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Schizophrenia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a randomized, single-blind, two-period crossover study in adults with schizophreniaMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04865835
- Collaborators
- Not Provided
- Investigators
- Study Chair: CNS Medical Director Sunovion