Status:
COMPLETED
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
Lead Sponsor:
Insmed Incorporated
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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/exclusion criteria may apply.
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05965570
Start Date
July 28 2023
End Date
September 22 2023
Last Update
December 11 2023
Active Locations (1)
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1
USA001
Dallas, Texas, United States, 75247