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

NCT ID: NCT05673603

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2023-02-14

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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (Mild Impairment): Brensocatib

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

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet

Cohort 2 (Moderate Impairment): Brensocatib

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

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet

Cohort 3 (Severe Impairment): Brensocatib

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

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet

Cohort 4 (Normal): 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.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet

Interventions

Brensocatib

Oral tablet

Intervention Type: DRUG

Other Intervention Names

INS1007

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.

• 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.

• 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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA002

Orlando, Florida, United States

USA003

Tampa, Florida, United States

USA001

San Antonio, Texas, United States

Countries

United States

References

Yeung SA, Stein DS, Marbury TC, Usansky H. The pharmacokinetics of brensocatib in participants with renal impairment following a single oral administration. Br J Clin Pharmacol. 2025 Apr;91(4):1191-1197. doi: 10.1111/bcp.16344. Epub 2024 Nov 22.

Reference Type: DERIVED

PMID: 39574348 (View on PubMed)

Other Identifiers

INS1007-102

Identifier Type: -

Identifier Source: org_study_id