Clinical trial NCT05673603: A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Brensocatib
INS1007
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
measure: Maximum Observed Plasma Concentration (Cmax) of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
measure: Number of Participants who Experienced at Least one Adverse Event (AE)
timeFrame: Up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: USA002
state: Florida
city: Tampa
country: United States
facility: USA003
state: Florida
city: San Antonio
country: United States
facility: USA001
state: Texas
Study officials:
References: