A SINGLE DOSE, OPEN LABEL STUDY EVALUATING THE PHARMACOKINETICS OF A LOW ORAL

评估低口服药的药代动力学的单剂量、开放标签研究

• 批准号: 8167318
• 负责人: ADELAIDE S ROBB
• 金额: $ 0.39万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-20 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167318
• 关键词: Age; Autistic Disorder; Body Weight; Childhood; Clinical assessments; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Exposure; Drug Formulations; Drug Kinetics; Enrollment; Funding; Grant; Institution; Laboratories; Memantine; Monitor; Oral; Patient Participation; Patients; Physical Examination; Research; Research Personnel; Resources; Safety; Source; Testing; United States National Institutes of Health; Weight; capsule; open label; sample collection

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label single-dose study conducted in 3 to 10 centers in four groups of pediatric patients with ASD, ages 5 to 16 years (inclusive), stratified by weight. A total of 24 patients will be enrolled (6 patients per group). Patients will be assigned to one of the following groups: Group A: 60 to 80 kg Group B: 40 to 59 kg Group C: 20 to 39 kg Group D: less than 20 kg Enrollment will proceed sequentially by group, with Group A patients enrolling first and Group D patients enrolling last. Following enrollment of Group A, each subsequent group of patients will be enrolled after 1) the pharmacokinetics of memantine have been evaluated for at least two patients in the preceding group and 2) drug exposure in terms of AUC for patients in the preceding group has been determined to be less than a predefined limit that is deemed to be safe. All patients will receive a single 3-mg dose of a memantine HCl MR capsule in the morning of Day 1. The total duration of each patient's participation in the study will be 8 days (Day 1 through the last PK sample collection on Day 8). Safety will be assessed throughout the study by monitoring AEs, physical examinations, ECGs, vital sign assessments, and clinical laboratory tests. The purpose of this study is to evaluate the pharmacokinetics of a single, low, oral dose of memantine HCl modified release formulation in four groups of pediatric patients with autism stratified by body weight.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项开放标签单剂量研究，在 3 至 10 个中心进行，分为四组儿童 ASD 患者，年龄 5 至 16 岁（含），按体重分层。共有24名患者 将被纳入（每组 6 名患者）。患者将被分配到其中之一 以下团体： A组：60至80公斤 B组：40至59公斤 C组：20至39公斤 D组：20公斤以下 入组将按组顺序进行，A 组患者先入组，A 组患者先入组 D 患者最后登记。 A 组入组后，后续各组患者 将在以下情况后入组： 1) 美金刚的药代动力学至少经过评估 前一组中的两名患者和 2) 中组患者的药物暴露（以 AUC 计） 前面的组已被确定为小于预定义的限制，该限制被认为是 安全的。所有患者将在治疗室中接受单次 3 毫克剂量的盐酸美金刚 MR 胶囊。 第一天早上。每位患者参与研究的总持续时间为 8 天（第 1 天到第 8 天最后一次 PK 样本收集）。 在整个研究过程中将通过监测 AE、体检、 心电图、生命体征评估和临床实验室测试。 本研究的目的是评估单次、低口服剂量的药代动力学 盐酸美金刚缓释制剂治疗四组自闭症儿科患者 按体重分层。