Clarithromycin + Brensocatib for Healthy Subjects
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.12345Why 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.678910Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brensocatib
- Clarithromycin
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
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Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor
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-StudyBrensocatib 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 ...
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: ...
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=c0bdc9c4a4412435157ba66ac2052ea2Approval 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 ...
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=consumerLabel: 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).
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 ...
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 ...
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 ...
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