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

NCT04325737 | Completed Phase 1

• 1 other identifier: DA801102
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  18 days

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

  21 days

Study Arms (2)

SEP-363856

EXPERIMENTAL

Drug: SEP-363856

Placebo

PLACEBO COMPARATOR

Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.

Drug: Placebo

Interventions

SEP-363856 DRUG

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.

SEP-363856

Placebo DRUG

Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (8)

Shiranui Hospital

Omuta-shi, Fukuoka, 836-0004, Japan

Location

Nishiurakai Keihan Hospital

Osaka-Fu, Moriguchi-shi, 570-0005, Japan

Location

Mental Support SOYOKAZE Hospital

Ueda-shi, Nagano, 386-0401, Japan

Location

NHO Ryukyu Hospital

Kunigami-gun, Okinawa, 904-1201, Japan

Location

NHO Hizen Psychiatric Center

Kanzaki, Saga-ken, 842-0104, Japan

Location

Rainbow & Sea Hospital

Karatsu-shi, Saga-ken, 847-0031, Japan

Location

Inuo Mental Care Hospital

Tosu, Saga-ken, 841-0081, Japan

Location

Kuramitsu Hospital

Fukuoka, 819-0037, 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 30, 2020
• Study Start: March 31, 2020
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

JP (8)