JPRN-jRCT2080223731已完成1 期
An Ascending Multiple Oral Dose, Open-Label Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •(1) Subject who has schizophrenia diagnosed by DSM-5, and in the opinion of the Investigator has been clinically stable.
- •(2)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.
- •(3) If the subject is 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.
- •(4) Subject who has body weight is 40.0 kg or more and BMI is 18.5 or more.
- •(5) Negative pregnancy test
- •(6) Taking appropriate contraceptive measures, etc.
排除标准
- •(1) Subject experienced an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months (90 days) before screening.
- •(2) Subjects who received any sustained-release formulation (depot preparation) of antipsychotic medications within 3 months (90 days) before screening.
- •(3) Subjects who received electroconvulsive therapy (ECT) within 3 months (90 days) before screening or is expected to require ECT during the study.
- •(4) Subjects has a history of alcohol or substance related disorders (according to DSM-5 criteria) within 6 months (180 days) before screening or a positive urine drug screen at screening.
- •(5) Subjects who received other investigational products or post-marketing clinical study drugs within 3 months (90 days) before screening or who have enrolled in but have not completed another clinical or post-marketing study before screening.
- •(6) Subjects with a history or complication 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. Pituitary tumors of any duration are excluded.
- •(7) Subjects are considered by the Investigator to be affected by potent central nervous system depressants (including barbiturate).
- •(8) Subjects with a history or complication of hypersensitivity to any medication
- •(9) 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.
- •(10) Subjects with specific suicidal ideation or those with a suicide attempt history
- •(11) 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.
研究者
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