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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.

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
placebo
SEP-363856
metformin
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
    • 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).

Sites / Locations

  • At Fort Lauderdale Behavioral Health Center
  • Hassman Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo and metformin

SEP-363856 and metformin

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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
• maximum observed plasma concentration
maximum observed plasma concentration (Cmax).

Secondary Outcome Measures

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 of the maximum observed plasma concentration
time of the maximum observed plasma concentration (tmax)
time of last quantifiable concentration
time of last quantifiable concentration (Tlast)
• percentage of extrapolated AUC0-∞
percentage of extrapolated AUC0-∞ (%AUCextrap)
terminal elimination half-life
terminal elimination half-life(T1/2)
apparent clearance
apparent clearance (CL/F)
apparent volume of distribution
apparent volume of distribution (VZ/F)
amount excreted in urine
amount excreted in urine (Ae)
percentage excreted in urine
percentage excreted in urine (Fe)
renal clearance
renal clearance (CLR)

Full Information

First Posted
April 26, 2021
Last Updated
May 31, 2022
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04865835
Brief Title
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.
Official Title
A Randomized, Single-blind, Two-period Crossover to Investigate the Effect of SEP-363856 on the Pharmacokinetics of Metformin in Subjects With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, single-blind, two-period crossover study in adults with schizophrenia
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo and metformin
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
SEP-363856 and metformin
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
single dose of placebo
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
single dose of SEP 363856 100 mg
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
metformin-HCl 850 mg
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve
Description
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
Title
• maximum observed plasma concentration
Description
maximum observed plasma concentration (Cmax).
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
area under the plasma concentration-time curve
Description
area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-last)
Time Frame
72 hours
Title
time of the maximum observed plasma concentration
Description
time of the maximum observed plasma concentration (tmax)
Time Frame
72 hours
Title
time of last quantifiable concentration
Description
time of last quantifiable concentration (Tlast)
Time Frame
72 hours
Title
• percentage of extrapolated AUC0-∞
Description
percentage of extrapolated AUC0-∞ (%AUCextrap)
Time Frame
72 hours
Title
terminal elimination half-life
Description
terminal elimination half-life(T1/2)
Time Frame
72 hours
Title
apparent clearance
Description
apparent clearance (CL/F)
Time Frame
72 hours
Title
apparent volume of distribution
Description
apparent volume of distribution (VZ/F)
Time Frame
72 hours
Title
amount excreted in urine
Description
amount excreted in urine (Ae)
Time Frame
72 hours
Title
percentage excreted in urine
Description
percentage excreted in urine (Fe)
Time Frame
72 hours
Title
renal clearance
Description
renal clearance (CLR)
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
At Fort Lauderdale Behavioral Health Center
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com

Learn more about this trial

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.

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