EUCTR2018-001064-30-BG进行中（未招募）1 期
A Phase 1, Open Label, Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Pimavanserin in Adolescents with Psychiatric Disorders
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Study Population
- •1. Male or female subjects between the ages of =13 and <18 years (Note: subjects must be <18 years by the end of the study)
- •2. Is within the 5th to 95th percentile for gender specific weight for-age and height-for-age Growth Charts from the National Center for Health Statistics
- •3. Is able to understand and provide signed informed assent, (informed consent if emancipated) and have a legal guardian who is able to provide signed informed consent
- •4. Where applicable, has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
- •5. In the Investigator’s opinion, the subject and parent/legal guardian are able to understand the nature of the trial, follow protocol requirements (including any inpatient stays required by the Investigator based on the subject’s clinical status), and be willing to comply with study drug administration requirements
- •Psychiatric Diagnosis and Concomitant Medications
- •6. Has a diagnosis of schizophrenia based on Diagnostic and Statistical Manual-5 [DSM-5]
- •7. Is judged by the Investigator to be both clinically stable (i.e., no psychiatric hospitalization within the past 12 weeks of Screening) and is not at imminent risk of suicide or injury to self, others, or property
- •8. Is on a standard of care psychotropic medication for their psychiatric condition
- •9. If the subject is taking two psychotropic medications at Screening, the Investigator will determine which psychotropic medication is the main treatment and, only if clinically appropriate, will discontinue the other at least 5 half lives before Baseline
- •a. Subjects with more than 2 psychotropic medications at Screening are not eligible for the study; see Appendix A for further prohibitions and restrictions for medication use during the study
- •Contraceptives
- •10. Female subjects who participate in this study must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) -OR- agree to use a highly effective non-hormonal method of contraception (e.g., intrauterine device, condom or diaphragm with spermicides, or contraceptive sponge) from Day -28 to 45 days after last dose
- •a. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine dipstick hCG pregnancy test at Baseline (Day 1)
- •11. Male subjects must agree to use a highly effective form of contraception (i.e., double-barrier method which includes a condom plus diaphragm with spermicide or condom plus spermicide) from Day -1 to 45 days after last dose. Male subjects must also agree to not donate sperm for the duration of the study and until 90 days after the last dose of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Requires treatment with a medication prohibited by the protocol
- •2. Is taking more than 2 psychotropic medications at Screening
- •3. Has a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure or drug induced seizure is not exclusionary.
- •4. Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator based upon all available sources of information including C-SSRS at Screening or Baseline and including more than one life-threatening suicide attempt
- •5. Has a significant risk of violent behavior
- •6. Has a positive urine drug or alcohol test at Screening or positive urine drug dipstick or breathalyzer alcohol test result at Baseline
- •7. Has met DSM-5 criteria for substance use disorders within the last 6 months prior to Baseline
- •8. Consumes either more than 21 units of alcohol per week or 4 units of alcohol per day; 1 unit of alcohol is equivalent to 236 mL of beer, 118 mL of wine, or 130 mL of spirits
- •9. Excessive use of nicotine-containing products within 30 days before study drug administration or is using or has used topical or oral nicotine preparations for smoking cessation within the past 30 days before study drug administration
- •10. Consumes greater than 500 mg of caffeine or xanthine-containing products per day
- •11. Refuses to limit caffeine or xanthine-containing products to no more than 100 mg per day during the study
- •12. Refuses to abstain from alcohol, grapefruit foods or beverages, or Seville-orange containing foods or beverages, from 48 hours prior to check-in on Day -1 through the end of the study
- •13. Has any condition that would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
- •14. Has current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study
- •15. Resting position systolic blood pressure (BP) >149 mmHg or <90 mmHg or semisupine diastolic BP >90 mmHg or <60 mmHg at Screening or at Baseline
- •16. Has at least one resting heart rate, as measured by ECG machine, <50 beats per minute (bpm) or >100 bpm at Screening (central vendor over-read ECGs) or at Baseline
- •17. Has a positive hepatitis B surface antigen or hepatitis C antibody test result at Screening
- •18. At Screening has a known history of a positive Human Immunodeficiency Virus (HIV) test result
- •19. Female subjects of childbearing potential who have a history of taking hormonal contraceptives within 30 days prior to Baseline (Day -1)
- •20. Has donated >500 mL of blood within 60 days prior to start of Screening
- •21. Has donated any plasma within 7 days prior to Baseline (Day -1)
- •22. Has 1 or more clinical laboratory test value(s) outside the range specified in the protocol, or any other clinically significant laboratory abnormality as determined by the Investigator or Medical Monitor at Screening
- •23. Has a history or presence in on at least one ECG at Screening (central vendor over-read ECGs) or at Baseline (tracings collected on the study-provided ECG device during the visit), of any of the cardiac conduction abnormalities set for
研究者
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