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 @ 5:10 AM
Ignite Modification Date:
2025-12-25 @ 5:10 AM
NCT ID:
NCT03928327
Eligibility Criteria:
Key Inclusion Criteria:
1. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study based on participant self-reporting.
2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the Investigator or designee. Has liver function tests (LFTs) including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin within the upper limit of normal at screening and at first check-in.
3. Normal baseline spirometry for forced vital capacity (FVC) and forced expiratory volume (FEV1)/FVC within 7 days prior to the first dosing based on the following normal FVC and FEV1/FVC range: a. 20 - 39 years of age: ≥ 80% and b. 40 - 55 years of age: ≥ 75%
4. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2, at screening.
Key Exclusion Criteria:
1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
2. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
3. Presence of an acute lung infection, within 3 months of screening.
4. History or presence of any previous lung disease.
5. Part 1 only: History or presence of any of the following, deemed clinically significant by the PI or designee, and as confirmed by the Sponsor:
* Ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome);
* Uncorrected hypokalemia (potassium levels \<3.7) and/or hypomagnesemia (magnesium levels \<1.9);
* Myasthenia gravis.
6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
7. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
8. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
9. QTcF interval is \>460 msec (males) or \>470 msec (females) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
10. Estimated creatinine clearance \<90 mL/min at screening
11. Unable to refrain from or anticipates the use of:
* Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the subject has been on the same stable dose for the immediate 3 months prior to the first dosing. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study, only after initial dosing.
* Any drugs known to be inhibitors or inducers of CYP3A enzymes and/or P-gp, including St. John's Wort, within 28 days prior to the first dosing and throughout the study. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction with study drugs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03928327
Study Brief:
Protocol Section:
NCT03928327