Healthy Volunteers
Conditions
Brief summary
The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.
Interventions
DRUGBrensocatib
Oral tablets.
DRUGClarithromycin
Oral tablets.
Sponsors
Insmed Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Females of nonchildbearing potential and males, of any race, between 18 and 65 years of age, inclusive, without current disease. * Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive, and a total body weight ≥50 kilograms (kg).
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). * 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 serology test results for hepatitis B panel or hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test. * Participants whose results are compatible with prior immunization for hepatitis B or natural immunity may be included at the discretion of the investigator. * Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or check-in. * Poor peripheral venous access. Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20 | The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experienced at Least one Adverse Event (AE) | Up to Day 27 | Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants. |
Countries
United States
Outcome results
None listed