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.

NCT04865835 | Completed Phase 1 FDA Drug

• 1 other identifier: SEP361-110
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

  72 hours

• • maximum observed plasma concentration

  maximum observed plasma concentration (Cmax).

  72 hours

Secondary Outcomes (10)

• area under the plasma concentration-time curve

  72 hours

• time of the maximum observed plasma concentration

  72 hours

• time of last quantifiable concentration

  72 hours

• • percentage of extrapolated AUC0-∞

  72 hours

• terminal elimination half-life

  72 hours

Study Arms (2)

placebo and metformin

PLACEBO COMPARATOR

single dose of placebo + single dose of metformin-HCl 850 mg (approximately 663 mg metformin) (placebo will be dosed 1 hour prior to metformin administration)

Drug: placebo; Drug: metformin

SEP-363856 and metformin

EXPERIMENTAL

single dose of SEP 363856 100 mg + single dose of metformin-HCl 850 mg (SEP 363856 will be dosed 1 hour prior to metformin administration)

Drug: SEP-363856; Drug: metformin

Interventions

placebo DRUG

single dose of placebo

placebo and metformin

SEP-363856 DRUG

single dose of SEP 363856 100 mg

SEP-363856 and metformin

metformin DRUG

metformin-HCl 850 mg

SEP-363856 and metformin; placebo and metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent.
• Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM 5 as a reference and confirmed using the Structured Clinical Interview for DSM 5, Clinical Trials Version \[SCID CT\]).
• Subject must have a Clinical Global Impressions - Severity Scale (CGI S) score ≤ 4 (normal to moderately ill) at Screening.
• Subject must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 at Screening.
• Subject must have a score of ≤ 4 on the following PANSS items at Screening:
• P7 (hostility) G8 (uncooperativeness).
• Subject must have normal to mild symptoms on all individual items of the Simpson-Angus Scale (SAS) (\< 2), Abnormal Involuntary Movement Scale (AIMS) (\< 3) and Barnes Akathisia Rating Scale (BARS) (\< 3) at Screening.
• Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted after Medical Monitor and Sponsor review) for at least six weeks prior to Screening.

You may not qualify if:

• Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study, including any clinically significant hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular, hepatic, neurologic or allergic disease (except for untreated seasonal allergies that are asymptomatic at the time of dosing).
• Subject has a disorder or history of a condition, or previous gastrointestinal surgery (eg, cholecystectomy, vagotomy, bowel resection) that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic or renal system, or a history of malabsorption (uncomplicated cholecystectomy, appendectomy, and hernia repair will be acceptable).
• Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia-Suicide Severity Rating Scale (C SSRS) at Screening (ie, in the past 1 month) or at any subsequent C SSRS assessment prior to dosing (ie since last visit).

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (2)

At Fort Lauderdale Behavioral Health Center

Oakland Park, Florida, 33334, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856; Metformin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, single-blind, two-period crossover study in adults with schizophrenia

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: May 12, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (2)