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).

NCT03370640 | Completed Phase 1 FDA Drug

• 2 other identifiers: DA801004JapicCTI-173787
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks in part 1, 3 weeks in part 2.

Secondary Outcomes (1)

• Plasma concentrations of SEP-363856 and its metabolite SEP-363854

  Twelve days in part 1, 16 days in part 2.

Study Arms (3)

SEP-363856 Part 1 Cohort 1

EXPERIMENTAL

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.

Drug: SEP-363856

SEP-363856 Part 1 Cohort 2

EXPERIMENTAL

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.

Drug: SEP-363856

SEP-363856 Part 2 Cohort 3

EXPERIMENTAL

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.

Drug: SEP-363856

Interventions

SEP-363856 DRUG

An oral 25 or 50mg dose of SEP 363856

SEP-363856 Part 1 Cohort 1; SEP-363856 Part 1 Cohort 2; SEP-363856 Part 2 Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (8)

Hotei Hospital

Kōnan, Aichi-ken, 483-8248, Japan

Location

Soushu Hospital

Atsugi, Kanagawa, 243-0201, Japan

Location

Mental Support SOYOKAZE Hospital

Ueda, Nagano, 386-0401, Japan

Location

Asakayama General Hospital

Sakai, Osaka, 590-0018, Japan

Location

Showa University Karasuyama Hospital

Setagaya-Ku, Tokyo, 157-8577, Japan

Location

Narimasu Kosei Hospital

Itabashi-Ku, 175-0091, Japan

Location

Yuge Hospital

Kumamoto, 861-8002, Japan

Location

National Hospital Organization Hizen Psychiatric Center

Saga, 842-0192, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 12, 2017
• Study Start: November 29, 2017
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

JP (8)