DMP 777 LUNG SPECIFIC ORAL ADMINISTRATION IN PATIENTS WITH CYSTIC FIBROSIS

DMP 777 囊性纤维化患者的肺部特异性口服给药

• 批准号: 6263489
• 负责人: DANIEL B ROSENBLUTH
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263489
• 关键词: clinical research; cystic fibrosis; drug administration rate /duration; drug screening /evaluation; elastase inhibitor; elastases; enzyme activity; extracellular; human subject; human therapy evaluation; lung lavage; metabolism disorder chemotherapy; neutrophil; oral administration; pharmacokinetics

The primary objectives are to assess the magnitude of extacellular human neutrophil elastase (NE) ingibitory activity in bronchoalveolar lavage (BAL) fluid following 14 days of oral DMP 777 administration twice daily or three times daily in adult patients with cystic fibrosis (CF) and to correlate this effect with any observed changes in extracellualar HNE activity in BAL fluid with systmeic pharmacokinetic (PK) and pharmacodynamic (PD) data. Evaluate the safety of DMP 777. The secondary objective is to determine the correlation between the magnitude of BAL extracellular HNE inhibition and improvement in biological indices relevant to the pathogenesis of lung disease in CF.

主要目的是评估成人囊性纤维化（CF）患者口服DMP 777后14天支气管肺泡灌洗液（BAL）中细胞外人中性粒细胞弹性酶（NE）的抑制活性的大小，并将这种作用与BAL液中观察到的细胞外HNE活性的变化与系统药代动力学（PK）和药效学（PD）数据联系起来。评估DMP 777的安全性。次要目的是确定BAL细胞外HNE抑制程度与CF中与肺部疾病发病机制相关的生物学指标改善之间的相关性。