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

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brensocatib
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring Brensocatib, INS1007

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USA002
  • USA003
  • USA001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 (Mild Impairment): Brensocatib

Cohort 2 (Moderate Impairment): Brensocatib

Cohort 3 (Severe Impairment): Brensocatib

Cohort 4 (Normal): Brensocatib

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
April 17, 2023
Sponsor
Insmed Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05673603
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Brensocatib, INS1007

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (Mild Impairment): Brensocatib
Arm Type
Experimental
Arm Description
Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Arm Title
Cohort 2 (Moderate Impairment): Brensocatib
Arm Type
Experimental
Arm Description
Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Arm Title
Cohort 3 (Severe Impairment): Brensocatib
Arm Type
Experimental
Arm Description
Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Arm Title
Cohort 4 (Normal): Brensocatib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brensocatib
Other Intervention Name(s)
INS1007
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib
Description
Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.
Time Frame
Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Title
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Time Frame
Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Title
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
Title
Number of Participants who Experienced at Least one Adverse Event (AE)
Description
Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.
Time Frame
Up to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
USA002
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
USA003
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
USA001
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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