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Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SEP-363856
Sponsored by
Sumitomo Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:The subjects who fulfill the following criteria will be included in the study.

  • Subjects who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who voluntarily provide written consent to participate in the study. If the subject is considered a minor or is hospitalized involuntarily at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
  • Japanese subject with schizophrenia between 18 to 55 years of age at the time of consent.
  • Subject who has schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
  • Subject who has body weight ≥ 40.0 kg and body mass index (BMI) ≥ 18.5 (BMI = body weight [kg] / [height (m)]2).
  • Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result at screening, and a negative urine pregnancy test result at clinic admission (Note: Positive urine pregnancy test will be confirmed by serum pregnancy test). Subjects who are not pregnant and are not nursing mothers.
  • Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and appropriate contraception throughout the study starting the day obtaining informed consent and for at least 30 days after the last study drug administration.
  • Subjects who are able to comply with the study requirements, including physical examination, assessments, and reporting symptoms.

Exclusion Criteria:The subjects who meet any of the following criteria will be excluded from the study.

  • Subject experienced an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months before screening.
  • Subjects who received any sustained-release formulation (depot preparation) of antipsychotic medications within 3 months before screening.
  • Subjects who received electroconvulsive therapy within 3 months before screening or is expected to require ECT during the study.
  • Subjects has a history of alcohol or substance related disorders (according to DSM-5 criteria) within 6 months before screening or a positive urine drug screen at screening.
  • Subjects who received other investigational products or post-marketing clinical study drugs within 3 months before screening or who have enrolled in but have not completed another clinical or post-marketing study before screening.
  • Subjects with a history or complication (s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell carcinoma of skin or cervix carcinoma in situ.
  • Subjects are considered by the Investigator to be affected by potent central nervous system depressants (including barbiturate).
  • Subjects have previous or existing infection with HIV at screening. Subjects have a positive test for Syphilis serum reaction, Hepatitis B surface antigen or Hepatitis C antibody at screening.
  • Subjects with specific suicidal ideation or those with a suicide attempt history
  • Subjects have 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, etc

Sites / Locations

  • Hotei Hospital
  • Soushu Hospital
  • Mental Support SOYOKAZE Hospital
  • Asakayama General Hospital
  • Showa University Karasuyama Hospital
  • Narimasu Kosei Hospital
  • Yuge Hospital
  • National Hospital Organization Hizen Psychiatric Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SEP-363856 Part 1 Cohort 1

SEP-363856 Part 1 Cohort 2

SEP-363856 Part 2 Cohort 3

Arm Description

An oral 25 mg dose of SEP 363856 once daily for 3 days, then 50 mg dose of SEP-363856 once daily for 7 days.

An oral 50 mg dose of SEP 363856 once daily for 3 days, then 75 mg dose of SEP-363856 once daily for 7 days.

An oral 25 mg dose of SEP 363856 once daily for 3 days, 50 mg dose of SEP 363856 once daily for 4 days, and then 75 mg dose of SEP-363856 once daily for 7 days.

Outcomes

Primary Outcome Measures

Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.

Secondary Outcome Measures

Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Plasma concentration ( Day -1 , Day 1, Day 10, and Day 11) in part 1, plasma concentration ( Day -1 , Day 1, Day 14, and Day 15) in part 2.

Full Information

First Posted
November 22, 2017
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03370640
Brief Title
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).
Official Title
A 2-Part Ascending Multiple Oral Dose, Open-Label Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.
Detailed Description
This multicenter study will be conducted in 2 parts (Part 1 and 2). This is an ascending multiple oral dose, open-label study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in male and female subjects with schizophrenia. In part 1, subjects will have up to two visits, including a screening visit, and a 17-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 10 days in-clinic dosing. From Day 11 through Day 13, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 14. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study prior to Day 13 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications. In Part 2, Subjects will have up to two visits, including a screening visit, and a 21-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 14 days in-clinic dosing. From Day 15 through Day 17, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 18. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study by Day 17 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications.

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
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856 Part 1 Cohort 1
Arm Type
Experimental
Arm Description
An oral 25 mg dose of SEP 363856 once daily for 3 days, then 50 mg dose of SEP-363856 once daily for 7 days.
Arm Title
SEP-363856 Part 1 Cohort 2
Arm Type
Experimental
Arm Description
An oral 50 mg dose of SEP 363856 once daily for 3 days, then 75 mg dose of SEP-363856 once daily for 7 days.
Arm Title
SEP-363856 Part 2 Cohort 3
Arm Type
Experimental
Arm Description
An oral 25 mg dose of SEP 363856 once daily for 3 days, 50 mg dose of SEP 363856 once daily for 4 days, and then 75 mg dose of SEP-363856 once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
An oral 25 or 50mg dose of SEP 363856
Primary Outcome Measure Information:
Title
Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
Description
adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
Time Frame
Two weeks in part 1, 3 weeks in part 2.
Secondary Outcome Measure Information:
Title
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Description
Plasma concentration ( Day -1 , Day 1, Day 10, and Day 11) in part 1, plasma concentration ( Day -1 , Day 1, Day 14, and Day 15) in part 2.
Time Frame
Twelve days in part 1, 16 days in part 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:The subjects who fulfill the following criteria will be included in the study. Subjects who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who voluntarily provide written consent to participate in the study. If the subject is considered a minor or is hospitalized involuntarily at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject. Japanese subject with schizophrenia between 18 to 55 years of age at the time of consent. Subject who has schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnostic criteria, and in the opinion of the Investigator has been clinically stable. Subject who has body weight ≥ 40.0 kg and body mass index (BMI) ≥ 18.5 (BMI = body weight [kg] / [height (m)]2). Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result at screening, and a negative urine pregnancy test result at clinic admission (Note: Positive urine pregnancy test will be confirmed by serum pregnancy test). Subjects who are not pregnant and are not nursing mothers. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and appropriate contraception throughout the study starting the day obtaining informed consent and for at least 30 days after the last study drug administration. Subjects who are able to comply with the study requirements, including physical examination, assessments, and reporting symptoms. Exclusion Criteria:The subjects who meet any of the following criteria will be excluded from the study. Subject experienced an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months before screening. Subjects who received any sustained-release formulation (depot preparation) of antipsychotic medications within 3 months before screening. Subjects who received electroconvulsive therapy within 3 months before screening or is expected to require ECT during the study. Subjects has a history of alcohol or substance related disorders (according to DSM-5 criteria) within 6 months before screening or a positive urine drug screen at screening. Subjects who received other investigational products or post-marketing clinical study drugs within 3 months before screening or who have enrolled in but have not completed another clinical or post-marketing study before screening. Subjects with a history or complication (s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell carcinoma of skin or cervix carcinoma in situ. Subjects are considered by the Investigator to be affected by potent central nervous system depressants (including barbiturate). Subjects have previous or existing infection with HIV at screening. Subjects have a positive test for Syphilis serum reaction, Hepatitis B surface antigen or Hepatitis C antibody at screening. Subjects with specific suicidal ideation or those with a suicide attempt history Subjects have 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, etc
Facility Information:
Facility Name
Hotei Hospital
City
Konan
State/Province
Aichi
ZIP/Postal Code
483-8248
Country
Japan
Facility Name
Soushu Hospital
City
Atsugi
State/Province
Kanagawa
ZIP/Postal Code
243-0201
Country
Japan
Facility Name
Mental Support SOYOKAZE Hospital
City
Ueda
State/Province
Nagano
ZIP/Postal Code
386-0401
Country
Japan
Facility Name
Asakayama General Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
Showa University Karasuyama Hospital
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
157-8577
Country
Japan
Facility Name
Narimasu Kosei Hospital
City
Itabashi-Ku
ZIP/Postal Code
175-0091
Country
Japan
Facility Name
Yuge Hospital
City
Kumamoto
ZIP/Postal Code
861-8002
Country
Japan
Facility Name
National Hospital Organization Hizen Psychiatric Center
City
Saga
ZIP/Postal Code
842-0192
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).

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