A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment

Insmed

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Brensocatib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05673603

INS1007-102

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Cohort 1 (Mild Impairment): Brensocatib

Experimental group

Description:

Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Treatment:

Drug: Brensocatib

Cohort 2 (Moderate Impairment): Brensocatib

Experimental group

Description:

Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Treatment:

Drug: Brensocatib

Cohort 3 (Severe Impairment): Brensocatib

Experimental group

Description:

Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Treatment:

Drug: Brensocatib

Cohort 4 (Normal): Brensocatib

Experimental group

Description:

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.

Treatment:

Drug: Brensocatib