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OpenTrials
Completed

NCT Number: NCT05673603

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA002, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brensocatib

Drug

Oral tablet

Other names: INS1007

Primary outcomes

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

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

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

  2. Maximum Observed Plasma Concentration (Cmax) of Brensocatib

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

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib

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

  4. Number of Participants who Experienced at Least one Adverse Event (AE)

    Time frame: Up to Day 14

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

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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