Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SEP-363856
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subjects who voluntarily provide written consent to participate in the study. If the subject is considered a minor 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.
- Subject who has schizophrenia diagnosed by DSM-5, diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
- Subject who has body weight >= 40.0kg and body mass index (BMI) >= 18.5.
- Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result.
- Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and reliable contraception.
other
Exclusion Criteria:
- Subjects who experienced an acute exacerbation of psychosis requiring change in antipsychotic medication (with reference to drug or dose) within 90 days before screening.
- Subjects who become strongly affected by potent central nervous system depressants (including barbiturate) as considered by the Investigator.
- Subjects who 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.
- Subjects with active suicidal ideation or those with a suicide attempt history.
- Subjects with a history or complication(s) of hypersensitivity to any medication.
- Subjects with a history or complication(s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
- Subjects who have previous or existing infection with human immunodeficiency virus (HIV) at screening.
- Subjects who have a positive syphilis serological test, Hepatitis B virus surface (HBs) antigen or Hepatitis C virus (HCV) antibody at screening.
other
Sites / Locations
- Shiranui Hospital
- Nishiurakai Keihan Hospital
- Mental Support SOYOKAZE Hospital
- NHO Ryukyu Hospital
- NHO Hizen Psychiatric Center
- Rainbow & Sea Hospital
- Inuo Mental Care Hospital
- Kuramitsu Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SEP-363856
Placebo
Arm Description
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
Outcomes
Primary Outcome Measures
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation
adverse events (AEs), serious adverse events (SAEs) in cohort 1.
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation
adverse events (AEs), serious adverse events (SAEs) in cohort 2.
Secondary Outcome Measures
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Plasma concentrations in cohort 1.
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Plasma concentrations in cohort 2.
Full Information
NCT ID
NCT04325737
First Posted
March 23, 2020
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04325737
Brief Title
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
Official Title
A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Study Assessing the Safety and Tolerability of SEP-363856 in Japanese Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
August 7, 2020 (Actual)
Study Completion Date
August 7, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multiple oral dose, randomized, double-blind, placebo-controlled study assessing the safety, tolerability and pharmacokinetics (PK) of SEP-363856 when administered qhs to Japanese subjects with schizophrenia.
Detailed Description
This multicenter study will be conducted in 2 cohorts (Cohort 1 and 2). Cohort transition will be determined by the Safety Review Team (SRT) before the start of Cohort 2.
For each cohort, the target number of subjects completing the treatment period is defined as 8 for SEP-363856 group and 4 for placebo group. Subjects will be randomly assigned to either group. Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. In the placebo group, placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEP-363856
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
Primary Outcome Measure Information:
Title
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation
Description
adverse events (AEs), serious adverse events (SAEs) in cohort 1.
Time Frame
18 days
Title
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation
Description
adverse events (AEs), serious adverse events (SAEs) in cohort 2.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Description
Plasma concentrations in cohort 1.
Time Frame
18 days
Title
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Description
Plasma concentrations in cohort 2.
Time Frame
21 days
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:
Subjects who voluntarily provide written consent to participate in the study. If the subject is considered a minor 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.
Subject who has schizophrenia diagnosed by DSM-5, diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
Subject who has body weight >= 40.0kg and body mass index (BMI) >= 18.5.
Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result.
Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and reliable contraception.
other
Exclusion Criteria:
Subjects who experienced an acute exacerbation of psychosis requiring change in antipsychotic medication (with reference to drug or dose) within 90 days before screening.
Subjects who become strongly affected by potent central nervous system depressants (including barbiturate) as considered by the Investigator.
Subjects who 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.
Subjects with active suicidal ideation or those with a suicide attempt history.
Subjects with a history or complication(s) of hypersensitivity to any medication.
Subjects with a history or complication(s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
Subjects who have previous or existing infection with human immunodeficiency virus (HIV) at screening.
Subjects who have a positive syphilis serological test, Hepatitis B virus surface (HBs) antigen or Hepatitis C virus (HCV) antibody at screening.
other
Facility Information:
Facility Name
Shiranui Hospital
City
Omuta-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
836-0004
Country
Japan
Facility Name
Nishiurakai Keihan Hospital
City
Osaka-Fu
State/Province
Moriguchi-shi
ZIP/Postal Code
570-0005
Country
Japan
Facility Name
Mental Support SOYOKAZE Hospital
City
Ueda-shi
State/Province
Nagano-Ken
ZIP/Postal Code
386-0401
Country
Japan
Facility Name
NHO Ryukyu Hospital
City
Kunigami-gun
State/Province
Okinawa-Ken
ZIP/Postal Code
904-1201
Country
Japan
Facility Name
NHO Hizen Psychiatric Center
City
Kanzaki
State/Province
Saga-Ken
ZIP/Postal Code
842-0104
Country
Japan
Facility Name
Rainbow & Sea Hospital
City
Karatsu-shi
State/Province
Saga-Ken
ZIP/Postal Code
847-0031
Country
Japan
Facility Name
Inuo Mental Care Hospital
City
Tosu
State/Province
Saga
ZIP/Postal Code
841-0081
Country
Japan
Facility Name
Kuramitsu Hospital
City
Fukuoka
ZIP/Postal Code
819-0037
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
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