Renal ImpairmentPhase 1NCT05673603
A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
A Phase 1 study testing Brensocatib in people with Renal Impairment, run by Insmed Incorporated at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Brensocatib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2021to 14 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
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- 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.
- Note: Other inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
USA002
Orlando, Florida, 32809
USA001
San Antonio, Texas, 78215
USA003
Tampa, Florida, 33603
About this study
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
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
- Being tested
- Brensocatib
- Keywords
- Brensocatib, INS1007
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrensocatibDrug
Also called INS1007
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Mild Impairment): Brensocatib | Experimental | Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Brensocatib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib
Measured: 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.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start20 Jul 2021
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673603
- Sponsor's protocol ID
- INS1007-102
- Status last verified
- Apr 2023
- First submitted
- 21 Dec 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39574348
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05673603
- Acronym / sponsor ID
- INS1007-102
- Conditions
- Renal Impairment
- Keywords
- Brensocatib, INS1007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Mild Impairment): Brensocatib | Experimental | Drug: BrensocatibParticipants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
| Cohort 2 (Moderate Impairment): Brensocatib | Experimental | Drug: BrensocatibParticipants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
| Cohort 3 (Severe Impairment): Brensocatib | Experimental | Drug: BrensocatibParticipants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
| Cohort 4 (Normal): Brensocatib | Experimental | Drug: BrensocatibHealthy 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrensocatibAlso: INS1007Oral tablet | Drug | Cohort 1 (Mild Impairment): Brensocatib, Cohort 2 (Moderate Impairment): Brensocatib, Cohort 3 (Severe Impairment): Brensocatib, Cohort 4 (Normal): Brensocatib |
Primary outcome
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.
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39574348Yeung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brensocatib in people with Renal Impairment, run by Insmed Incorporated at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.