An Open-label, Single Ascending Dose, Pharmacokinetic and Tolerability Study of NFC-1 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder

Aevi Genomic Medicine, LLC, a Cerecor company3 个研究点分布在 1 个国家目标入组 32 人开始时间: 2017年1月7日最近更新: 2021年7月6日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 32
试验地点: 3
主要终点: Terminal Half Life (T½ ) of NFC-1

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 is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) 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: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Subject and parent/legally authorized representative (LAR) are able to speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
•Subject is 6 to 17 years inclusive at the time of consent/assent.
•Subject is male, female of non-childbearing potential or non-pregnant, non-lactating female of childbearing potential who agrees to comply with any applicable contraceptive requirements 2 weeks prior to administration of IP and throughout the study.
•Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International Neuropsychiatric Interview.
•Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination.
•Subject has the ability to swallow a capsule of investigational product whole.

排除标准

•Subject has a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD.
•Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
•Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
•Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
•Subject has used an investigational product, been enrolled in a clinical study including vaccines, or had any changes in eating habits, within 30 days prior to the first dose of investigational product.
•Subject has a positive screen for alcohol or drugs of abuse, or a positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV antibody screen.
•Subject previously was an adolescent (12-17) who was either a screen failure, or enrolled or participated in this study or another NFC1 clinical study.
•Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
•Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study.
•Subject is unwilling to discontinue current ADHD medication to participate in the study.
•Subject has a clinical laboratory abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.

研究组 & 干预措施

NFC-1 100 mg

Experimental

Single Dose of NFC-1 100 mg

干预措施: NFC-1 100 mg (Drug)

NFC-1 200 mg

Experimental

Single Dose of NFC-1 200 mg

干预措施: NFC-1 200 mg (Drug)

NFC-1 400 mg

Experimental

Single Dose of NFC-1 400 mg

干预措施: NFC-1 400 mg (Drug)

NFC-1 800 mg

Experimental

Single Dose of NFC-1 800 mg

干预措施: NFC-1 800 mg (Drug)