A Phase 1b, Multicenter, Open-label, Multiple Ascending Dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (4 to 12 Years, Inclusive) With Attention-deficit/Hyperactivity Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2020年6月11日最近更新: 2022年6月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Otsuka Pharmaceutical Development & Commercialization, Inc.
入组人数: 32
试验地点: 1
主要终点: Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 4 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
•Subjects must weight ≥ 13 kg.
•Subjects with a diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria and confirmed by the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid).
•Subject is judged by the investigator to be clinically stable, and has not had any psychiatric hospitalizations within the past 12 weeks.
•Subjects and their caregivers must be able and willing to utilize the AiCure Platform for each daily dose.

排除标准

•Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another psychiatric or general medical condition(s) or direct effect of a substance.
•Subjects with developmental disorders, such as Autism Spectrum Disorder.
•Subjects with a history of at least mild intellectual disability as determined by IQ < 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
•Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to first dose of IMP) or an abnormal result for free T4 at screening.
•Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/AIDS, or chronic hepatitis B or C.
•Subjects with insulin dependent diabetes mellitus (i.e. any subjects using insulin)
•Subjects with epilepsy, Tourette's Disorder, or a history of seizures or a history of severe head trauma or cerebrovascular disease.
•Any major surgery within 30 days prior to the first dose of IMP.
•Any history of significant bleeding or hemorrhagic tendencies.
•Blood transfusions within 30 days prior to the first dose of IMP.
•Subjects who have supine or standing diastolic blood pressure, after resting for at least 5 minutes, > 80 mmHg.
•Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year. Subjects who have had any previous exposure to centanafadine.
•Subjects with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary drug exposure.
•Subjects with a history of allergic reaction or known or suspected sensitivity to any substance that is contained in the IMP formulation.
•Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for collecting blood samples.
•Consumption of alcohol and/or food and beverages containing methylxanthines, foods known to affect CYP1A2 (e.g. charbroiled or pan-fried meats and cruciferous vegetables) within 72 hours prior to dosing.
•Relative of the trial site employees cannot participate in the trial.
•Siblings, other family members, and those having the same place of residence as the subject are also excluded from the trial.