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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT01944735
Eligibility Criteria:
Inclusion Criteria:
1. Adult male or female, 18 to 55 years of age (inclusive) at the time of screening.
2. Confirmed diagnosis of CF based on the following: positive sweat chloride or sodium value ≥ 60 mEq/L, and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype or a diagnosis of CF made by a specialist in this condition.
3. In the judgment of the Principal Investigator (PI), the patient is medically stable with no change in symptoms, medication, or with clinical laboratory results that in PI opinion are compatible with the diagnosis of either CF or a complication thereof and are judged acceptable for inclusion.
4. Body mass index (BMI) ≥ 17.0 (kg/m2).
5. Non-tobacco/nicotine-containing product user for a minimum of 6 months prior to the first study drug administration.
6. Forced Expiratory Volume (FEV1) of \>50% and \<90% of predicted at screening.
7. Must agree to use adequate method of contraception.
Exclusion Criteria:
1. Patient has displayed any significant clinical/laboratory/radiological/spirometric sign of unstable or unexpectedly deteriorating respiratory disease within 30 days prior to the first study drug administration.
2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease that depart from the patient's usual baseline level of health as a patient with CF.
3. Has a history of lung transplantation.
4. History or presence of alcoholism or drug abuse within 2 years prior to the first study drug administration.
5. Personal or family history of prolonged QT syndrome; or a QTc interval \>430 msec (males) or \>450 msec (females) using Bazett's formula (QTcB) or deemed clinically significant by the PI.
6. Sitting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg, unless deemed clinically insignificant by the PI.
7. Pulse is higher than 100 b.p.m or lower than 50 b.p.m. unless deemed clinically insignificant by the PI.
8. Failure to satisfy the PI of fitness to participate for any other reason.
9. In the judgment of the PI, clinically significant hemoptysis (\>30 cc per episode) within the last 180 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01944735
Study Brief:
Protocol Section:
NCT01944735