Clarithromycin + Brensocatib for Healthy Subjects

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how clarithromycin, an antibiotic, affects the body's processing of brensocatib, a potential new treatment for certain lung conditions. Researchers will administer both drugs to healthy participants to study their interaction. The trial specifically targets healthy individuals without ongoing medical conditions and with a body mass index between 18.0 and 32.0. Participants must not have significant allergies, past surgeries affecting drug absorption, or positive tests for certain viruses. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that brensocatib has been studied for use in conditions like non-cystic fibrosis bronchiectasis, a lung condition, in adults and children aged 12 and older. In these studies, participants generally tolerated brensocatib well, with common side effects being mild, such as headaches and stomach upset.

Clarithromycin, combined with brensocatib in this trial, is a commonly used antibiotic. When taken as prescribed, it is usually safe, though some people might experience side effects like nausea or diarrhea.

This study is in an early phase, focusing on how brensocatib and clarithromycin work together in the body. Limited safety data exists for their combination, as the early phase aims to understand their interaction in the body rather than evaluate detailed safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about brensocatib because it offers a novel approach to managing conditions like bronchiectasis by targeting a specific enzyme called DPP1. This enzyme plays a role in activating neutrophil serine proteases, which can cause inflammation and damage in the lungs. Unlike traditional treatments that mainly focus on reducing symptoms or infections, brensocatib works by potentially preventing the underlying inflammation process. This unique mechanism could lead to improved lung health and fewer flare-ups, making it a promising option for patients who have limited effective treatments available.

What evidence suggests that this trial's treatments could be effective?

Research has shown that brensocatib reduces lung problems in people with bronchiectasis. It decreases the number of annual lung flare-ups and slows the decline of lung function, making breathing easier and improving well-being. Patients using brensocatib have reported better quality of life. The evidence supporting brensocatib is strong, with consistent results across various studies.

In this trial, participants will receive a combination of brensocatib and clarithromycin. Clarithromycin, primarily an antibiotic, can lower lung bacteria levels, which benefits some lung conditions. However, it does not improve overall health or reduce lung flare-ups in conditions like COPD, a type of lung disease. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brensocatib
• Clarithromycin

How Is the Trial Designed?

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+

Citations

1. investor.insmed.com investor.insmed.com/2025-05-21-Brensocatib-Shows-Consistent-Efficacy-and-Safety-Across-Three-Prespecified-Subgroups-in-New-Data-from-Landmark-ASPEN-Study

Brensocatib Shows Consistent Efficacy and Safety Across ... Brensocatib 25-mg reduced lung function decline and numerically improved Quality of Life-Bronchiectasis Respiratory Symptoms Domain score (QOL-B ...

2. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2411664

Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in ... Among patients with bronchiectasis, once-daily treatment with brensocatib (10 mg or 25 mg) led to a lower annualized rate of pulmonary exacerbations than ...

3. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/brensocatib-in-bronchiectasis-beneficial-even-with-copd/

Brensocatib Beneficial in Bronchiectasis Regardless of ... Brensocatib reduced the decline in FEV1 among patients with and without COPD (week 52 least squares mean difference (mL) vs placebo with COPD: ...

4. icer.org icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-evidence-report-on-treatment-for-non-cystic-fibrosis-bronchiectasis/

Institute for Clinical and Economic Review Publishes ... “ICER's analyses found that brensocatib, the first medication to be specifically indicated for NCFB, reduces the rate of pulmonary exacerbations ...

5. breath-hannover.de breath-hannover.de/en/news-media/news/news-details.html?tx_news_pi1%5Bnews%5D=898&cHash=c0bdc9c4a4412435157ba66ac2052ea2

Approval of the First Drug for Bronchiectasis Disease in Sight A positive outcome, emphasizes the bronchiectasis expert: “Brensocatib reduced the risk of symptom exacerbation, slowed the decline in lung ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05965570

NCT05965570 | A Study to Investigate Effect of ... Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants.

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b56986ae-e7db-421e-b622-a7f41e321f3d&audience=consumer

Label: BRINSUPRI- brensocatib tablet - DailyMed The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479633/

A Phase IIa, Single-Blind, Placebo-Controlled, Parallel ... The PK, PD, and safety data from this study support future clinical development of brensocatib for the treatment of CF. Acknowledgements. We ...

9. rxlist.com rxlist.com/brinsupri-drug.htm

Brinsupri (Brensocatib Tablets): Side Effects, Uses, Dosage ... The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis ...

10. clinicaltrials.eu clinicaltrials.eu/inn/brensocatib/

Brensocatib: A Comprehensive Guide for Patients The CEDAR study is a Phase 2b trial evaluating the efficacy and safety of Brensocatib at doses of 10 mg and 40 mg in adults with moderate to severe hidradenitis ...