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 is Eligible

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

Eligibility Criteria

  • 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
  • Cannot have any other lung diseases or any unstable medical condition
  • Abnormal laboratory results
  • Women cannot be pregnant or breastfeeding
  • Women cannot be using a 5-lipoxygenase (5-LO) inhibitor (e.g. zileuton); leukotriene receptor antagonists (e.g. montelukast or zafirlukast); systemic corticosteroids or systemic antibiotic antimicrobial therapy (other than chronic antimicrobial use such as azithromycin; flucloxacillin; itraconazole use for CF) within 14 days before screening or between screening and baseline

What is involved

  • Informed consent
  • Demographics and disease characteristics
  • Height and calculation of BMI
  • Urine alcohol and drug screen
  • Randomization
  • Serum pregnancy test
  • HIV & HCV antibodies
  • 2 Medical history questionnaires
  • 13 Physical exams
  • 10 12-lead ECGs
  • 13 Weigh-ins
  • 14 Vital sign checks
  • 12 Pulse oximetrys
  • 5 Questionnaires CFQ-Re
  • 12 Spirometrys
  • 15 Pulmonary exacerbation checklists
  • 5 Sputum samples
  • 11 Hematology tests
  • 14 Serum chemistry tests
  • 10 Questionnaires hs-CRP
  • 11 Urinalysises
  • 12 Urine pregnancy tests
  • 3 PK samples
  • 8 IP dispensings
  • 10 IP collection & capsule counts
  • AE & concomitant medication recording (continuously during the trial)

Compensation

$1,150 if you complete all the scheduled study visits. You will paid for completed visits if you withdraw from the study. Visit 1, 2, 5, 9, 15, 16: $100 each. Visit 3, 6, 7, 8, 11, 13: $75 each. Visit 4, 10, 12, 14: $25 each.

Contact Information

Study Coordinator
Bob Hmieleski
Email
[email protected]
Phone
-8550
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.