To test a new Cystic Fibrosis drug called CTX-4430.

What we are studying

The drug we are testing in this study is called CTX-4430. Since it is still being studied, it is not yet approved or available for doctors to prescribe. It has been tested in people with and without cystic fibrosis. People with cystic fibrosis have taken CTX-4430 for 15 days. In these studies, CTX 4430 was well tolerated. We think CTX-4430 works by treating the inflamed tissue in the lungs of people with cystic fibrosis. Now we want to get more information on how well it works in treating people with cystic fibrosis and how safe and tolerable it is when taken once a day by mouth for 48 weeks.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 30

Eligibility Criteria

  • Potential participants need to be diagnosed with Cystic Fibrosis and on a stable dose for 14 days
  • If on ivacaftor or ivacaftor-lumacaftor combination
  • On a stable regimen for at least 8 weeks before Baseline. No smoking (including electronic cigarettes) for at least 6 months before Screening and agreement not to use such products for the duration of the study. The potential participant cannot have any other lung diseases
  • Any medical condition that is unstable
  • Abnormal laboratory results
  • Female cannot be pregnant or breastfeeding or using a 5-lipoxygenase (5-LO) inhibitor (e.g.
  • Zileuton)
  • Leukotriene receptor antagonists (e.g. montelukast
  • Zafirlukast)
  • Systemic corticosteroids
  • Or systemic antibiotic antimicrobial therapy (other than chronic antimicrobial use
  • E.G. azithromycin
  • Flucloxacillin
  • Itraconazole use for CF) within 14 days before Screening or between Screening and Baseline

What is involved

  • Informed consent (once) Demographics & disease characteristics (once) Medical history (twice) Physical exam (13 times) 12-lead ECG (10 times) Height
  • Calculation of BMI (once) Weight (13 times) Vital signs (14 times) Pulse oximetry (12 times) Questionnaire CFQ-Re (5 times) Spirometry (12 times) Pulmonary exacerbation checklist (15 times) Sputum sample (5 times) Hematology (11 times) Serum chemistry (14 times) Questionnaire hs-CRP (10 times) Serum pregnancy test (once) HIV & HCV antibodies
  • (Once) Urinalysis (11 times) Urine pregnancy test (12 times) Urine alcohol and drug screen (once) Randomization (once) PK samples (3 times) IP dispensing (8 times) IP collection and capsule count (10 times) AE & concomitant medication recording (continuously during the trial)


You will be paid $1150.00 if you complete all the scheduled study visits. If you withdraw for any reason from the study before completion you will be paid the following for each complete study visit. Visit 1 screening $100.00 Visit 2 baseline $100.00

Contact Information

Study Coordinator
Bob Hmieleski
Principal Investigator
Victor Ortega

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.