Study of CTX 4430 in Cystic Fibrosis Patients
Details
- Therapeutic approach
- Anti-Inflammatory
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001601
- Last updated
- 09/11/2017
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis
Study detailsThe 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.
- Phase
- Phase 2
- Length of participation
- 55 weeks
- Recruitment target
- 195
- CF sponsor
- Celtaxsys, Inc
- CF sponsor type
- Commercial
Who can take part?
- Age range
- Between 18 and 30 years
- Including people
18 to 30 years of age inclusive at the time of Screening
FEV1 ≥50 percent predicted at Screening
At least 1 pulmonary exacerbation in the 12 months before Screening- Excluding people
History of organ transplantation
History of alcoholism or drug abuse within 2 years before Screening
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