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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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ClinicalTrials.gov Identifier: NCT04325737
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SEP-363856 Drug: Placebo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 31, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: SEP-363856 Drug: SEP-363856
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.
Placebo Comparator: Placebo
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
 Drug: Placebo
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation [ Time Frame: 18 days ]
    adverse events (AEs), serious adverse events (SAEs) in cohort 1.

  2. Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation [ Time Frame: 21 days ]
    adverse events (AEs), serious adverse events (SAEs) in cohort 2.


Secondary Outcome Measures :
  1. Plasma concentrations of SEP-363856 and its metabolite SEP-363854 [ Time Frame: 18 days ]
    Plasma concentrations in cohort 1.

  2. Plasma concentrations of SEP-363856 and its metabolite SEP-363854 [ Time Frame: 21 days ]
    Plasma concentrations in cohort 2.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject who has schizophrenia diagnosed by DSM-5, diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
  3. Subject who has body weight >= 40.0kg and body mass index (BMI) >= 18.5.
  4. Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result.
  5. 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:

  1. Subjects who experienced an acute exacerbation of psychosis requiring change in antipsychotic medication (with reference to drug or dose) within 90 days before screening.
  2. Subjects who become strongly affected by potent central nervous system depressants (including barbiturate) as considered by the Investigator.
  3. 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.
  4. Subjects with active suicidal ideation or those with a suicide attempt history.
  5. Subjects with a history or complication(s) of hypersensitivity to any medication.
  6. 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.
  7. Subjects who have previous or existing infection with human immunodeficiency virus (HIV) at screening.
  8. Subjects who have a positive syphilis serological test, Hepatitis B virus surface (HBs) antigen or Hepatitis C virus (HCV) antibody at screening.

other

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325737


Contacts
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Contact: Sumitomo Dainippon Pharma Co. Ltd. E-mail only cc@ds-pharma.co.jp

Locations
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Japan
Shiranui Hospital Not yet recruiting
Omuta-shi, Fukuoka-Ken, Japan, 836-0004
Contact: Michihiko Matsushita    +81-944552000      
Nishiurakai Keihan Hospital Recruiting
Osaka-Fu, Moriguchi-shi, Japan, 570-0005
Contact: Hiroyuki Nishiura    +81-669082019      
Mental Support SOYOKAZE Hospital Not yet recruiting
Ueda-shi, Nagano-Ken, Japan, 386-0401
Contact: Tomotaka Yoshida    +81-268350305      
NHO Ryukyu Hospital Not yet recruiting
Kunigami-gun, Okinawa-Ken, Japan, 904-1201
Contact: Taku Otsuru    +81-989682133      
NHO Hizen Psychiatric Center Not yet recruiting
Kanzaki, Saga-Ken, Japan, 842-0104
Contact: Naoya Oribe    +81-952523231      
Rainbow & Sea Hospital Not yet recruiting
Karatsu-shi, Saga-Ken, Japan, 847-0031
Contact: Taro Shindo    +81-955770711      
Inuo Mental Care Hospital Not yet recruiting
Tosu, Saga, Japan, 841-0081
Contact: Akifumi Inuo    +81-942827007      
Kuramitsu Hospital Not yet recruiting
Fukuoka, Japan, 819-0037
Contact: Noriko Tamaru    +81-928111821      
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
More Information
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Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04325737    
Other Study ID Numbers: DA801102
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders