EUCTR2013-001523-39-Outside-EU/EEA进行中（未招募）不适用
A PHASE 1 OPEN-LABEL, MULTICENTER, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF LURASIDONE IN SUBJECTS 6 TO 17 YEARS OLD WITH SCHIZOPHRENIA SPECTRUM, BIPOLAR SPECTRUM, AUTISTIC SPECTRUM DISORDER, OR OTHER PSYCHIATRIC DISORDERS - D1050300
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1. Subjects must provide written informed assent and be willing to participate in the study.
- •Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
- •2. Male or female subjects 6 to 17 years of age, inclusive.
- •3. Subject is judged by the investigator to be clinically stable (i.e., no psychiatric hospitalization within the past 12 weeks; no imminent risk of suicide or injury to self, others or property; no recent addition, or change in dosage, of psychotropic medication intended for the treatment of the primary psychiatric condition in the past 4 weeks) but symptomatic (i.e., some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option).
- •4. Subjects with the following diagnoses will be eligible for participation: primary schizophrenia spectrum diagnosis (schizophrenia, schizoaffective, schizophreniform or psychotic disorder Not Otherwise Specified (NOS), bipolar spectrum disorder (bipolar I, II or bipolar NOS), pervasive developmental disorder (PDD) including autistic spectrum disorder (autistic disorder, Asperger’s syndrome, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), attention-deficit hyperactivity (ADHD) with aggressive behavior [meeting co-morbid diagnostic criteria for Conduct Disorder/Disruptive Behavior Disorders Not Otherwise Specified (CD/DBD NOS)], or Tourette’s syndrome, via clinical interview (using MINI-Kid plus diagnostic interview and the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) as a reference). Autistic disorder should also be confirmed by the Autism Diagnostic Interview, Revised (ADI-R).
- •5. Willing and able to remain off any antipsychotic medication other than lurasidone for the duration of the study, if, in the investigator’s opinion the subject is not at risk for worsening symptoms.
- •6. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
- •7. Have a stable living arrangement for at least 3 months prior to Day -1 and agrees to return to a similar living arrangement after discharge on Day 11. Homeless subjects may not be enrolled.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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. Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal,
- •hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological
- •disorder such as unstable angina, congestive heart failure (uncontrolled), or central
- •nervous system (CNS) infection that would pose a risk to the subjects if they were to
- •participate in the study or that might confound the results of the study.
- •2. Known presence or history of hepatic insufficiency or subject’s estimated creatinine
- •clearance is < 80 mL/min/1.73 m2 by the following Bedside Schwartz equation for use
- •with creatinine methods with calibration traceable to isotope dilution mass spectrometry
- •(IDMS): Creatinine clearance (mL/min/1.73 m2) = (0.41 x height) / serum creatinine
- •concentration, where height in cm and serum creatinine in mg/dL.
- •3. A history or presence of abnormal ECG, which in the investigator’s opinion is clinically
- •significant. Screening ECGs will be centrally over-read, and eligibility will be
- •determined based on the over-read.
- •4. Clinically significant alcohol abuse/dependence or drug abuse/dependence based on
- •MINI-Kid criteria within the last 6 months prior to screening.
- •5. Clinically significant orthostatic hypotension (i.e., a drop in systolic blood pressure of
- •20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing up).
- •6. Use of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge on Day 11. Exceptions (e.g., for grapefruit juice consumption) may be discussed on a case-by-case basis with the medical monitor.
- •7. Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to Day -1 to follow-up.
- •8. Use of any antipsychotic medication (other than study drug), carbamazepine,
- •oxcarbazepine or fluvoxamine, within 3 days prior to Day -1 (7 days prior to Day -1 for
- •aripiprazole) and until follow-up.
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