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

NCT05673603 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1007-102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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

Keywords

Brensocatib; INS1007

Outcome Measures

Primary Outcomes (4)

• Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib

  Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.

  Pre-dose and at multiple timepoints post-dose on Days 1 to 14

• 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)

  Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.

  Up to Day 14

Study Arms (4)

Cohort 1 (Mild Impairment): Brensocatib

EXPERIMENTAL

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

Drug: Brensocatib

Cohort 2 (Moderate Impairment): Brensocatib

EXPERIMENTAL

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

Drug: Brensocatib

Cohort 3 (Severe Impairment): Brensocatib

EXPERIMENTAL

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

Drug: Brensocatib

Cohort 4 (Normal): Brensocatib

EXPERIMENTAL

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.

Drug: Brensocatib

Interventions

Brensocatib DRUG

Oral tablet

Also known as: INS1007

Cohort 1 (Mild Impairment): Brensocatib; Cohort 2 (Moderate Impairment): Brensocatib; Cohort 3 (Severe Impairment): Brensocatib; Cohort 4 (Normal): Brensocatib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (3)

USA002

Orlando, Florida, 32809, United States

Location

USA003

Tampa, Florida, 33603, United States

Location

USA001

San Antonio, Texas, 78215, United States

Location

Related Publications (1)

• 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.

  PMID: 39574348 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

brensocatib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: July 20, 2021
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)