Healthy VolunteersPhase 1NCT07859007
A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
A Phase 1 study testing Brensocatib and Midazolam in people with Healthy Volunteers, run by Insmed Incorporated.
Trial summary
The primary objective of this study is to assess the effect of multiple doses of brensocatib on the single dose PK of oral midazolam when coadministered in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brensocatib and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 25 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2).
- Normal renal function as determined by estimated glomerular filtration rate and calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
- Resting blood pressure of 90 to 140 milligrams of mercury (mmHg) (systolic) and 40 to 90 mmHg (diastolic).
- Judged by the Investigator to be 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
- History or clinical manifestations of a significant neurological, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, oncologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- History of relevant drug and/or food allergies (i.e., allergy to brensocatib or midazolam or any excipients, or any significant food allergy).
- Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines, methamphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and/or at admission to the clinical site.
- Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus 1 and 2 antibodies at screening. A positive result for HCV antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
- Donation or loss of more than 450 milliliters (mL) of blood within 30 days prior to the first study drug administration.
- Unsuitable veins for blood sampling.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study Assessing the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics of Midazolam in Healthy Participants
The primary objective of this study is to assess the effect of multiple doses of brensocatib on the single dose PK of oral midazolam when coadministered in healthy male and female participants.
- Conditions
- Healthy Volunteers
- Being tested
- Brensocatib, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrensocatibDrug
Also called INS1007
Oral tablets
MidazolamDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Midazolam + Brensocatib | Experimental | Participants will receive a single oral dose of midazolam on Day 1. From Days 2 to 13, participants will receive brensocatib administered orally, once daily. On Day 14, participants will receive a single oral dose of midazolam coadministered with a single oral dose of brensocatib. Receives: Drug: Brensocatib; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Midazolam and its Metabolite
Measured: Pre-dose and at multiple timepoints post-dose (up to Day 15)
Secondary outcomes (2)
Number of Participants Who Experienced At Least One Adverse Event (AE)
Measured: Up to day 21
Plasma Concentration of Brensocatib
Measured: Pre-dose and at multiple timepoints post-dose up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start29 Oct 2026 (estimated)
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859007
- Sponsor's protocol ID
- INS1007-111
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study Assessing the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics of Midazolam in Healthy Participants
- ClinicalTrials.gov ID
- NCT07859007
- Acronym / sponsor ID
- INS1007-111
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 5 Oct 2026 (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 objective of this study is to assess the effect of multiple doses of brensocatib on the single dose PK of oral midazolam when coadministered in healthy male and female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam + Brensocatib | Experimental | Drug: Brensocatib, Drug: MidazolamParticipants will receive a single oral dose of midazolam on Day 1. From Days 2 to 13, participants will receive brensocatib administered orally, once daily. On Day 14, participants will receive a single oral dose of midazolam coadministered with a single oral dose of brensocatib. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2).
- Normal renal function as determined by estimated glomerular filtration rate and calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
- Resting blood pressure of 90 to 140 milligrams of mercury (mmHg) (systolic) and 40 to 90 mmHg (diastolic).
- Judged by the Investigator to be 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 (7 listed)
- History or clinical manifestations of a significant neurological, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, oncologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- History of relevant drug and/or food allergies (i.e., allergy to brensocatib or midazolam or any excipients, or any significant food allergy).
- Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines, methamphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and/or at admission to the clinical site.
- Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus 1 and 2 antibodies at screening. A positive result for HCV antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
- Donation or loss of more than 450 milliliters (mL) of blood within 30 days prior to the first study drug administration.
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 tablets | Drug | Midazolam + Brensocatib |
| MidazolamOral solution | Drug | Midazolam + Brensocatib |
Primary outcome
Plasma Concentration of Midazolam and its Metabolite
Time frame: Pre-dose and at multiple timepoints post-dose (up to Day 15)
2 secondary outcomes
Number of Participants Who Experienced At Least One Adverse Event (AE)
Time frame: Up to day 21
Plasma Concentration of Brensocatib
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Study Director study director
Insmed Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brensocatib and Midazolam in people with Healthy Volunteers, run by Insmed Incorporated.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insmed Medical Information (18444467633, medicalinformation@insmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Midazolam and its Metabolite (time frame: Pre-dose and at multiple timepoints post-dose (up to Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.