Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Parion Sciences
With
Vertex Pharmaceuticals Incorporated
Age
12–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, 12 years of age or older.
Diagnosis of cystic fibrosis as determined by the 1997 CF Consensus criteria (NIH Consensus Statement, 1997)
Non-smoker
FEV1 at Screening Visit 1 between 40% and 90%
Stable regimen of CF medications and chest physiotherapy for the 28 days prior to Screening. Must be willing to discontinue use of hypertonic saline for the duration of the study.
Clinically stable for at least 2 weeks
All females of child-bearing potential must have a negative serum pregnancy test and if sexually active must agree to practice a highly effective form of contraception throughout the study and for 28 days after the last dose of study medication.
You may not be if
History of any organ transplantation or any significant disease or disorder
Use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs or trimethoprim in the 28 days prior to Screening
History of significant intolerance to inhaled hypertonic saline, as determined by the Investigator
Known hypersensitivity to the study drug or amiloride
Any clinically significant laboratory abnormalities at Screening Visit 1 as judged by the investigator, or any of the following:
* Potassium ≥ 5 milliequivalent per Liter (mEq/L)
* Abnormal renal function
* Abnormal liver function, defined as ≥ 3 x upper limit of normal (ULN)
* Hemoglobin level \< 10.0 g/dL
Female who is pregnant or lactating
History of sputum or throat swab culture yielding Burkholderia species or Mycobacterium abscessus within 2 years of screening
Has previously participated in an investigational trial involving administration of any investigational compound or use of an investigational device with 28 days prior to Screening
Currently being treated with any ivacaftor containing regimen
Clareo Health | Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
