Hepatic ImpairmentPhase 1NCT05517525
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
A Phase 1 study testing Brensocatib in people with Hepatic Impairment, run by Insmed Incorporated at 3 sites in United States.
Trial summary
The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic 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
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2022to 1 Jun 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has body mass index (BMI) between 18.0 and 35.0 kilogram per square meter (kg/m^2)
- Inclusion Criteria for Participants With Hepatic Impairment:
- Clinical diagnosis of chronic hepatic disease, as documented in their medical history of underlying hepatic insufficiency with features of cirrhosis and no acute episodes of illness within 30 days prior to screening, and no significant change in disease status from screening to check-in.
- Hepatic impairment will be classified using the Child-Pugh criteria
- A stable medication regimen, defined as not starting new drug(s) or changing dosage(s) within 30 days prior to study drug administration. Concomitant medications must be approved by the investigator and medical monitor.
- Inclusion Criteria for Healthy Matched Control Participants With Normal Hepatic Function:
- In good health, determined by no clinically significant findings from medical history, clinical laboratory evaluations, vital signs measurements, 12-lead electrocardiogram (ECG), and physical examination at screening or check-in, as assessed by the investigator (or designee).
- Matched to hepatically impaired participants in age (±10 years), sex, and BMI (±20%).
Who cannot join
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- Positive human immunodeficiency virus (HIV) test
- Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 30 days prior to dosing.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing.
- Use of moderate to strong CYP3A4 inducers or inhibitors within 14 days prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received the IMP.
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- Exclusion Criteria for Participants With Hepatic Impairment:
- Positive urine drug screen at screening or check-in, unless the result is due to a prescribed medication.
- History of significant immunologic impairment such as transplantation.
- Hepatic encephalopathy Grade ≥2 using Child-Pugh scoring.
- Exclusion Criteria for Healthy Matched Control Participants with Normal Hepatic Function
- Positive urine drug screen at screening or check-in.
- Significant history or clinical manifestation of any immunologic, metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Positive hepatitis panel. Participants whose results are compatible with prior immunization are eligible at the discretion of the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
USA003
Orlando, Florida, 32809
USA002
Rialto, California, 92377
USA001
San Antonio, Texas, 78215
About this study
Official title: An Open-label, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Brensocatib in Subjects With Normal Hepatic Function and Subjects With Hepatic Impairment
The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Brensocatib
- Keywords
- Brensocatib, INS1007
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: Brensocatib | Experimental | Healthy participants with normal hepatic 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 hepatic impairment. Receives: Drug: Brensocatib |
| Cohort 2: Brensocatib | Experimental | Participants with mild hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Receives: Drug: Brensocatib |
| Cohort 3: Brensocatib | Experimental | Participants with moderate hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Receives: Drug: Brensocatib |
| Cohort 4: Brensocatib | Experimental | Participants with severe hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. Receives: Drug: Brensocatib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Time Curve (AUC)
Comparison of the pharmacokinetics of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Secondary outcomes (2)
Fraction Unbound (Fu)
Assessment of the plasma protein binding of brensocatib in participants with varying degrees of hepatic function relative to matched healthy control participants with normal hepatic function.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
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 hepatic impairment.
Measured: From first dose of study drug up to follow up visit (5-7 days after discharge) or early termination (up to Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start4 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 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 Hepatic 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
- 30 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
- NCT05517525
- Sponsor's protocol ID
- INS1007-105
- Status last verified
- Jul 2023
- First submitted
- 24 Aug 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Usansky H, Au Yeung S, Li S, Marbury T, Lawitz E, Kayali Z, Stein DS. Pharmacokinetics and Safety of a Single Dose of Brensocatib in Participants with Hepatic Impairment and Matched Participants with Normal Hepatic Functions. Clin Pharmacokinet. 2026 Mar;65(3):441-452. doi: 10.1007/s40262-025-01614-0. Epub 2026 Jan 26.
PubMed 41586857
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Brensocatib in Subjects With Normal Hepatic Function and Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05517525
- Acronym / sponsor ID
- INS1007-105
- Conditions
- Hepatic Impairment
- Keywords
- Brensocatib, INS1007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Aug 2022 (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 compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
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: Brensocatib | Experimental | Drug: BrensocatibHealthy participants with normal hepatic 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 hepatic impairment. |
| Cohort 2: Brensocatib | Experimental | Drug: BrensocatibParticipants with mild hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
| Cohort 3: Brensocatib | Experimental | Drug: BrensocatibParticipants with moderate hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
| Cohort 4: Brensocatib | Experimental | Drug: BrensocatibParticipants with severe hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has body mass index (BMI) between 18.0 and 35.0 kilogram per square meter (kg/m^2)
- Clinical diagnosis of chronic hepatic disease, as documented in their medical history of underlying hepatic insufficiency with features of cirrhosis and no acute episodes of illness within 30 days prior to screening, and no significant change in disease status from screening to check-in.
- Hepatic impairment will be classified using the Child-Pugh criteria
- A stable medication regimen, defined as not starting new drug(s) or changing dosage(s) within 30 days prior to study drug administration. Concomitant medications must be approved by the investigator and medical monitor.
- In good health, determined by no clinically significant findings from medical history, clinical laboratory evaluations, vital signs measurements, 12-lead electrocardiogram (ECG), and physical examination at screening or check-in, as assessed by the investigator (or designee).
Key exclusion criteria (14 listed)
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- Positive human immunodeficiency virus (HIV) test
- Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 30 days prior to dosing.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing.
- Use of moderate to strong CYP3A4 inducers or inhibitors within 14 days prior to check-in.
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: Brensocatib, Cohort 2: Brensocatib, Cohort 3: Brensocatib, Cohort 4: Brensocatib |
Primary outcome
Area Under the Concentration Time Curve (AUC)
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Comparison of the pharmacokinetics of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
2 secondary outcomes
Fraction Unbound (Fu)
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Number of Participants who Experienced at Least one Adverse Event (AE)
Time frame: From first dose of study drug up to follow up visit (5-7 days after discharge) or early termination (up to Day 17)
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 19 Jul 2023.
- Derived from this study: PubMed 41586857Usansky H, Au Yeung S, Li S, Marbury T, Lawitz E, Kayali Z, Stein DS. Pharmacokinetics and Safety of a Single Dose of Brensocatib in Participants with Hepatic Impairment and Matched Participants with Normal Hepatic Functions. Clin Pharmacokinet. 2026 Mar;65(3):441-452. doi: 10.1007/s40262-025-01614-0. Epub 2026 Jan 26.
- 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 Hepatic 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 8 inclusion and 14 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 19 Jul 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 Concentration Time Curve (AUC) (time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9). 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 NCT05517525, 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 19 Jul 2023.