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

Overseen By Insmed Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Insmed Incorporated

Disqualifiers: Metabolic, Hepatic, Renal, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

What is the purpose of this trial?

This trial aims to see how taking clarithromycin changes the way brensocatib is processed in healthy people. Brensocatib is currently being developed for the treatment of bronchiectasis and other chronic inflammatory diseases.

Eligibility Criteria

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

You have a history of or ongoing significant health issues affecting your metabolism, allergies, skin, liver, kidneys, blood, lungs, heart, stomach, brain, breathing, hormones, or mental health, as determined by the researcher or their team.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of brensocatib on Days 1 and 13, and oral doses of clarithromycin twice daily from Days 8 to 19. On Day 13, brensocatib is coadministered with clarithromycin.

3 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Brensocatib
• Clarithromycin

Participant Groups

Group I: Brensocatib + Clarithromycin Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials

44

Recruited

7,600+