A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
NCT ID: NCT05965570
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2023-07-28
2023-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brensocatib + Clarithromycin
Participants will receive a single oral dose of brensocatib in the morning on Days 1 and 13 after an overnight fast, and oral doses of clarithromycin, twice daily (BID), with food on Days 8 to 19. On Day 13, brensocatib will be coadministered with the morning dose of clarithromycin. Clarithromycin can be taken with food, with the exception of the morning dose on the day of coadministration with brensocatib (Day 13), which will be taken after an overnight fast.
Brensocatib
Oral tablets.
Clarithromycin
Oral tablets.
Interventions
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Brensocatib
Oral tablets.
Clarithromycin
Oral tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA001
Dallas, Texas, United States
Countries
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Other Identifiers
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INS1007-109
Identifier Type: -
Identifier Source: org_study_id