Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGBrensocatib
Oral tablets
DRUGMidazolam
Oral solution
Sponsors
Insmed Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Concentration of Midazolam and its Metabolite | Pre-dose and at multiple timepoints post-dose (up to Day 15) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to day 21 |
| Plasma Concentration of Brensocatib | Pre-dose and at multiple timepoints post-dose up to Day 15 |
Contacts
CONTACTInsmed Medical Information
STUDY_DIRECTORStudy Director
Insmed Incorporated
Outcome results
None listed