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:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04279769
Eligibility Criteria:
Inclusion Criteria:
1. Written Informed Consent in accordance with federal, local, and institutional guidelines
2. Confirmed diagnosis of cystic fibrosis
3. Male or female subjects ≥ 18 years on the date of informed consent
4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
5. Clinically stable with no significant changes in health status within 28 days prior to Day 1
6. Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then
7. Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
8. Hemoglobin \> 10 g/dL at screening
9. Glomerular filtration rate \> 50 mL/min/1.73 m2 at screening
10. Normal liver function at screening
Exclusion Criteria:
1. History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study
2. Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus)
3. Unable to receive study medication per os (PO)
4. Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04279769
Study Brief:
Protocol Section:
NCT04279769