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

• ClinicalTrials.gov Identifier: NCT04325737
• Recruitment Status: Completed
• First Posted: March 30, 2020
• Last Update Posted: April 12, 2022
• Sponsor: Sumitomo Pharma Co., Ltd.
• Information provided by (Responsible Party): Sumitomo Pharma Co., Ltd.

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.

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 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
• Actual Study Start Date: March 31, 2020
• Actual Primary Completion Date: August 7, 2020
• Actual Study Completion Date: August 7, 2020

Arms and Interventions

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

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

• 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

Locations

Japan

Shiranui Hospital

Omuta-shi, Fukuoka-Ken, Japan, 836-0004

Nishiurakai Keihan Hospital

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

Mental Support SOYOKAZE Hospital

Ueda-shi, Nagano-Ken, Japan, 386-0401

NHO Ryukyu Hospital

Kunigami-gun, Okinawa-Ken, Japan, 904-1201

NHO Hizen Psychiatric Center

Kanzaki, Saga-Ken, Japan, 842-0104

Rainbow & Sea Hospital

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

Inuo Mental Care Hospital

Tosu, Saga, Japan, 841-0081

Kuramitsu Hospital

Fukuoka, Japan, 819-0037

Sponsors and Collaborators

Sumitomo Pharma Co., Ltd.

More Information

• Responsible Party: Sumitomo Pharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04325737
• Other Study ID Numbers: DA801102
• First Posted: March 30, 2020
• Last Update Posted: April 12, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders