[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658999":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":11,"studyPopulation":11,"armGroups":26,"interventions":34,"overallOfficials":46,"centralContacts":50,"locations":11,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":11},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Plasma Concentration of Midazolam and its Metabolite",null,"Pre-dose and at multiple timepoints post-dose (up to Day 15)",[14,17],{"measure":15,"description":11,"timeFrame":16},"Number of Participants Who Experienced At Least One Adverse Event (AE)","Up to day 21",{"measure":18,"description":11,"timeFrame":19},"Plasma Concentration of Brensocatib","Pre-dose and at multiple timepoints post-dose up to Day 15",{"allocation":21,"interventionModel":22,"interventionModelDescription":11,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"NA","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":11,"whoMasked":11},"NONE",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"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.",[32,33],"Drug: Brensocatib","Drug: Midazolam",[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Brensocatib","Oral tablets",[28],[41],"INS1007",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"Midazolam","Oral solution",[28],[47],{"name":48,"affiliation":5,"role":49},"Study Director","STUDY_DIRECTOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},"Insmed Medical Information","CONTACT","18444467633","medicalinformation@insmed.com",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658999","phase-1-a-study-to-assess-the-potential-cyp3a-induction-effect-of-brensocatib-on-the-pharmacokinetics-pk-of-midazolam-in-healthy-participants-100658999",false,"NCT07859007","A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants","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","Key Inclusion Criteria:\n\n* Body mass index between 18.0 and 32.0 kilograms per square meter (kg\u002Fm\\^2).\n* Normal renal function as determined by estimated glomerular filtration rate and calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.\n* Resting blood pressure of 90 to 140 milligrams of mercury (mmHg) (systolic) and 40 to 90 mmHg (diastolic).\n* 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.\n\nKey Exclusion Criteria:\n\n* 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.\n* History of relevant drug and\u002For food allergies (i.e., allergy to brensocatib or midazolam or any excipients, or any significant food allergy).\n* Positive drug and\u002For alcohol screen (opiates, methadone, cocaine, amphetamines, methamphetamines \\[including ecstasy\\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and\u002For at admission to the clinical site.\n* 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.\n* Donation or loss of more than 450 milliliters (mL) of blood within 30 days prior to the first study drug administration.\n* Unsuitable veins for blood sampling.\n\nNOTE: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":70,"type":71},26,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","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.",[77],"Healthy Volunteers","NOT_YET_RECRUITING","2026-09-29",{"date":81,"type":82},"2026-10-05","ACTUAL",{"date":84,"type":71},"2026-10-29",{"date":86,"type":71},"2026-11-25",{"name":5,"class":6}]