PHARMACOKINETICS AND SAFETY OF INTRAVENOUS TOPIRAMATE IN ADULT PATIENTS

成人患者静脉注射托吡酯的药代动力学和安全性

• 批准号: 7951634
• 负责人: JAMES C. CLOYD
• 金额: $ 0.77万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951634
• 关键词: Adult; Adverse effects; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Development; Disease; Dose; Drug Formulations; Drug Kinetics; Funding; Grant; Human; Infusion procedures; Institution; Intravenous; Investigational Drugs; Label; Maintenance; Measures; Medical; Neonatal; Neurologic; Newborn Infant; Oral; Orphan; Patients; Pilot Projects; Plasma; Radioactive; Research; Research Personnel; Resources; Safety; Seizures; Site; Source; Time; Treatment Protocols; United States National Institutes of Health; design; neonatal hypoxic-ischemic brain injury; neonate; neuroprotection; novel; safety study; topiramate

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. The aim of this first-in-humans study in adults taking oral topiramate (TPM) is to provide information essential to the further development of TPM as an orphan product for the treatment of neonatal seizures in newborns with hypoxic-ischemic encephalopathy (HIE), a rare medical disorder. Prior to studies of investigational drugs in newborns, the FDA requires that studies first be done in adults. We are carrying out a pharmacokinetic and safety study of a novel, intravenous TPM formulation in adult patients taking oral TPM. A small (25 mg) dose of a stable-labeled (non-radioactive) TPM is given at the same time as the patient takes his or her usual morning dose. Infusion site, systemic, and neurological adverse effects are assessed. Plasma TPM concentrations from both oral and IV TPM doses are measured and a full pharmacokinetic profile can be determine without interrupting patients' maintenance regimen. Results from this pilot study will inform the design of subsequent studies, including controlled clinical trials intended to determine the efficacy and safety of IV TPM for neuroprotection and seizure control in neonates.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项在口服托吡酯（TPM）的成人中进行的首次人体研究的目的是为进一步开发TPM作为治疗新生儿缺氧缺血性脑病（HIE）（一种罕见医学疾病）的孤儿药提供必要信息。 在对新生儿进行研究药物研究之前，FDA要求首先在成人中进行研究。 我们正在口服TPM的成人患者中进行一项新型静脉TPM制剂的药代动力学和安全性研究。 小剂量（25 mg）的稳定标记（非放射性）TPM与患者服用他或她通常的早晨剂量同时给予。 评估输注部位、全身和神经系统不良反应。 测量来自口服和IV TPM剂量的血浆TPM浓度，并且可以在不中断患者的维持方案的情况下确定完整的药代动力学曲线。 该初步研究的结果将为后续研究的设计提供信息，包括旨在确定IV TPM用于新生儿神经保护和癫痫控制的有效性和安全性的对照临床试验。