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

Renal Impairment Clinical Trial

Official title:

A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05673603
• Other study ID #: INS1007-102
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2021
• Est. completion date: February 14, 2023

Study information

• Verified date: April 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Brensocatib
Oral tablet

Locations

Country	Name	City	State
United States	USA002	Orlando	Florida
United States	USA001	San Antonio	Texas
United States	USA003	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of Brensocatib		Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib		Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Primary	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