DMP 777 PHARMACOKINETICS AND PHARMACODYNAMICS IN CYSTIC FIBROSIS

DMP 777 囊性纤维化的药代动力学和药效学

• 批准号: 6263488
• 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/6263488
• 关键词: blood chemistry; clinical research; cystic fibrosis; drug administration rate /duration; drug screening /evaluation; elastase inhibitor; elastases; enzyme activity; human subject; human therapy evaluation; metabolism disorder chemotherapy; neutrophil; oral administration; pharmacokinetics; urea

To evaluate safety and tolerabilty of multiple oral doses of DMP 777 in six different dose levels: to determine PK and PD characteristics of multiple oral doses of DMP 777 ata six different dose levels: to define DMP 777 dosage level necessary to achieve sustained high-level systemic neutrophil elastase inhibion as determined by measurements of circulating PMN-lysate AAPVase inhibition and whole blood urea fragment levels in selectively defined cohort of patients with CF following twice daily (every 12 hours) or three times daily (every 8 hours) oral administration of DMP 777 for 9 days duration. TOTAL: DMP 777-004, A Phase IIA Multiple Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics an Pharmacoknymics of Multiple Doses of DMP 777 in Adult Patients 18 Years of Age and Older with Cystic Fibrosis.

评估六种不同剂量水平下多次口服剂量的 DMP 777 的安全性和耐受性：确定六种不同剂量水平下多次口服剂量的 DMP 777 的 PK 和 PD 特征：确定达到持续高水平所需的 DMP 777 剂量水平通过测量循环 PMN 裂解物 AAPV 酶抑制和全血尿素片段水平来确定全身性中性粒细胞弹性蛋白酶抑制，在选择性定义的 CF 患者队列中每天两次后（每 12 小时）或每日 3 次（每 8 小时）口服 DMP 777，持续 9 天。总计：DMP 777-004，一项 IIA 期多剂量递增研究，旨在评估 18 岁及以上囊性纤维化成人患者中多剂量 DMP 777 的安全耐受性药代动力学和药代学。