DOSE RANGING EFFICACY, SAFETY, AND PHARMACOKINETIC STUDY OF RS25259

RS25259 的剂量范围疗效、安全性和药代动力学研究

• 批准号: 5219416
• 负责人: Barbara A. Murphy
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5219416
• 关键词: antineoplastics; clinical research; dosage; drug adverse effect; drug screening /evaluation; human subject; pharmacokinetics

The purposes of this study are: (1) To determine the dose-response relationship among single intravenous doses of RS-25259 over the dose range 0.3-30 ug/kg. The primary endpoint will be the proportion of patients with a complete antiemetic response (no vomiting or retching) for 24 hours after highly emetogenic chemotherapy, in chemotherapy-naive cancer patients. The efficacy of each dose will be compared with the efficacy of the lowest dose. (2) To assess the safety of single intravenous doses of RS-25259 administered through the range of doses tested in this patient population. (3) To assess the pharmacokinetics of single intravenous doses of RS-25259 through the range of doses tested in this patient population.

本研究的目的是：(1)确定剂量反应