Status:
COMPLETED
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 w...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04325737
Start Date
March 31 2020
End Date
August 7 2020
Last Update
April 12 2022
Active Locations (8)
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1
Shiranui Hospital
Omuta-shi, Fukuoka, Japan, 836-0004
2
Nishiurakai Keihan Hospital
Osaka-Fu, Moriguchi-shi, Japan, 570-0005
3
Mental Support SOYOKAZE Hospital
Ueda-shi, Nagano, Japan, 386-0401
4
NHO Ryukyu Hospital
Kunigami-gun, Okinawa, Japan, 904-1201