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

• Status: Completed
• Trial end date: 2020-08-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

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