RANDOM MULTIPLE DOSE PLACEBO-CONTROLLED STUDY OF ARI-509 IN DIABETIC PATIENTS

ARI-509 在糖尿病患者中的随机多剂量安慰剂对照研究

• 批准号: 5218374
• 负责人: MARY KORYTKOWSKI
• 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/5218374
• 关键词: aldehyde reductase; blood chemistry; blood glucose; carbohydrate metabolism; clinical research; clinical trial phase I; diabetes mellitus; diabetes mellitus therapy; dosage; drug screening /evaluation; erythrocytes; fructose; human subject; human therapy evaluation; nerve; oxidoreductase inhibitor; pharmacokinetics; sorbitol

The objective of this study is to assess the clinical safety and tolerance of ARI-509, a new aldose reductase inhibitor, in diabetic patients; to assess the pharmacokinetics of ARI-509 after multiple doses by measuring the plasma, erythrocyte (RBC) and sural nerve concentrations of ARI-509; and to assess preliminary pharmacodynamics of ARI-509 by serial measurement of sorbitol, fructose and glucose levels.

本研究的目的是评估临床安全性和 新型醛糖还原酶抑制剂 ARI-509 在糖尿病患者中的耐受性 患者;评估多次给药后 ARI-509 的药代动力学 通过测量血浆、红细胞 (RBC) 和腓肠神经浓度 ARI-509；并通过以下方法评估 ARI-509 的初步药效学： 山梨醇、果糖和葡萄糖水平的连续测量。