A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
- Registration Number
- NCT05673603
- Lead Sponsor
- Insmed Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (Mild Impairment): Brensocatib Brensocatib Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Cohort 3 (Severe Impairment): Brensocatib Brensocatib Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Cohort 2 (Moderate Impairment): Brensocatib Brensocatib Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Cohort 4 (Normal): Brensocatib Brensocatib Healthy participants with normal renal function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with renal impairment.
- Primary Outcome Measures
Name Time Method Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib Pre-dose and at multiple timepoints post-dose on Days 1 to 14 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
USA002
🇺🇸Orlando, Florida, United States
USA003
🇺🇸Tampa, Florida, United States
USA001
🇺🇸San Antonio, Texas, United States
USA002🇺🇸Orlando, Florida, United States