Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 in Cystic Fibrosis Patients
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety and tolerability of multiple oral doses of
CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This
study will include two dose levels. For each dose level, blood samples will be collected for
exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory
biomarker analysis. Following multiple dose administration, pulmonary function and
exploratory lung clearance index (LCI) measurements will be taken.