DMP 777 PHARMACOKINETICS AND PHARMACODYNAMICS IN CYSTIC FIBROSIS

评价6种不同剂量下口服多剂量DMP 777的安全性和耐受性：测定6种不同剂量下口服多剂量DMP 777的PK和PD特性；在选择性定义的CF患者队列中，通过测量循环pmn裂解物AAPVase抑制和全血尿素片段水平，确定实现持续高水平全身中性粒细胞弹性酶抑制所需的DMP 777剂量水平，这些患者每天两次（每12小时）或每天三次（每8小时）口服DMP 777，持续9天。TOTAL: DMP 777-004，一项IIA期多剂量递增研究，评估18岁及以上囊性纤维化成年患者多剂量DMP 777的安全性、耐受性、药代动力学和药代动力学。

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.