Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT03450720
Eligibility Criteria:
Inclusion Criteria:
* Male subject ≥18 years of age on the day of signing the informed consent form (ICF).
* A confirmed clinical diagnosis of CF.
* Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
* Weight ≥40 kg.
* Exocrine pancreatic insufficiency (documented in the subject's medical record).
* Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.
* Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
Exclusion Criteria:
* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
* History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).
* Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03450720
Study Brief:
Protocol Section:
NCT03450720