Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia

A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Study Assessing the Safety and Tolerability of SEP-363856 in Japanese Subjects With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SEP-363856; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 819-0037
    • Kuramitsu Hospital
  • Fukuoka-Ken
    • Omuta-shi, Fukuoka-Ken, Japan, 836-0004
      • Shiranui Hospital
  • Moriguchi-shi
    • Osaka-Fu, Moriguchi-shi, Japan, 570-0005
      • Nishiurakai Keihan Hospital
  • Nagano-Ken
    • Ueda-shi, Nagano-Ken, Japan, 386-0401
      • Mental Support Soyokaze Hospital
  • Okinawa-Ken
    • Kunigami-gun, Okinawa-Ken, Japan, 904-1201
      • NHO Ryukyu Hospital
  • Saga
    • Tosu, Saga, Japan, 841-0081
      • Inuo Mental Care Hospital
  • Saga-Ken
    • Kanzaki, Saga-Ken, Japan, 842-0104
      • NHO Hizen Psychiatric Center
    • Karatsu-shi, Saga-Ken, Japan, 847-0031
      • Rainbow & Sea Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation	adverse events (AEs), serious adverse events (SAEs) in cohort 1.	18 days
Frequency of AEs, serious adverse events (SAEs), and AEs resulting in study discontinuation	adverse events (AEs), serious adverse events (SAEs) in cohort 2.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of SEP-363856 and its metabolite SEP-363854	Plasma concentrations in cohort 1.	18 days
Plasma concentrations of SEP-363856 and its metabolite SEP-363854	Plasma concentrations in cohort 2.	21 days

Collaborators and Investigators

• Sponsor: Sumitomo Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2020
• Primary Completion (ACTUAL): August 7, 2020
• Study Completion (ACTUAL): August 7, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: DA801102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No