A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

• Status: Completed
• Trial end date: 2023-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Clarithromycin

Criteria

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/exclusion criteria may apply.