Study of CTX 4430 in Cystic Fibrosis Patients

Details

Therapeutic category
Anti-Inflammatory
Trial status
Closed to recruitment - in follow up Participating Centres
Phase
Phase II/III

Full title

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

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.

Trial Reference Number
51654
Trial type
Medication
Length of participation
55 weeks
Intervention
Anti-inflammatory
Recruitment target
195
Last edited date
09/11/2017
CF sponsor
Celtaxsys, Inc
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • 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
Top exclusion criteria
  • History of organ transplantation
  • History of alcoholism or drug abuse within 2 years before Screening

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