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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT05673603
Eligibility Criteria:
Inclusion Criteria:
* Has a body mass index (BMI) 18 to 35 kilograms per square meter (kg/m\^2), inclusive, and a body weight of ≥50 kg at Screening.
Inclusion Criteria (for Participants With Renal Impairment):
* Mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (eGFR) and calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
* Renal insufficiency or other related concomitant medical conditions (e.g., hypertension, anemia) has remained stable for at least 3 months before study drug dosing.
Inclusion Criteria for Healthy Participants:
* Normal renal function as determined by eGFR and calculated using the CKD-EDI formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
* In good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings.
Exclusion Criteria:
* Positive test result for human immunodeficiency virus types 1 or 2 antibodies, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies.
* History of relevant drug and/or food allergies (i.e., allergy to brensocatib or any excipients, or any significant food allergy).
* The participant has received study drug in another investigational study within 30 days of Screening.
Exclusion Criteria (for Participants With Renal Impairment):
* Has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin \<3.0 grams per deciliter (g/dL), and then confirmed if proteinuria \>5 g/day.
* Has an extrarenal cause of renal impairment (e.g., rapidly growing, space occupying lesions, adrenal enlargement).
* Has a functioning renal transplant (participant may be included in the study if he or she had a failed renal transplant and is not taking immunosuppressants).
* Has a hemoglobin value less than 8.5 g/dL.
* Has Type 1 or Type 2 diabetes mellitus.
Exclusion Criteria (for Healthy Participants):
* Has used any prescription (excluding hormonal birth control, hormone replacement therapy, nonsteroidal anti-inflammatory drugs, or acetaminophen) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before study drug dosing and throughout the study.
Note: Other inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05673603
Study Brief:
Protocol Section:
NCT05673603