Renal Impairment
Conditions
Keywords
Brensocatib, INS1007
Brief summary
The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.
Interventions
DRUGBrensocatib
Oral tablet
Sponsors
Insmed Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 | Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants. |
| Maximum Observed Plasma Concentration (Cmax) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 | — |
| Number of Participants who Experienced at Least one Adverse Event (AE) | Up to Day 14 | Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants. |
Countries
United States
Outcome results
None listed