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Brensocatib + Clarithromycin for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and at multiple timepoints post-dose on days 1 to 8, and days 13 to 20
Awards & highlights

Study Summary

This trial tests how a drug affects the body after one dose in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 8, and days 13 to 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 8, and days 13 to 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib
Secondary outcome measures
Number of Participants who Experienced at Least one Adverse Event (AE)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brensocatib + ClarithromycinExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620
Clarithromycin
2017
Completed Phase 4
~3950

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,180 Total Patients Enrolled

Media Library

Brensocatib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05965570 — Phase 1
Healthy Subjects Research Study Groups: Brensocatib + Clarithromycin
Healthy Subjects Clinical Trial 2023: Brensocatib Highlights & Side Effects. Trial Name: NCT05965570 — Phase 1
Brensocatib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965570 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently looking to enroll participants in this clinical trial?

"Clinicaltrials.gov attests to the fact that recruitment for this medical experiment is still in progress; having been initially published on July 28th 2023 and last amended on August 11th 2023."

Answered by AI

How many individuals are being recruited for this research endeavor?

"Correct. Information hosted on clinicaltrials.gov reveals that this trial is actively searching for 22 participants from 1 site, with the initial post dated July 28th 2023 and most recent update occurring on August 11th 2023."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned Brensocatib in conjunction with Clarithromycin?

"Our team has assigned a score of 1 to the safety profile of Brensocatib + Clarithromycin, as this is an early stage trial with limited data available on efficacy and safety."

Answered by AI

Is the age restriction for enrollment in this trial higher than 25 years old?

"The inclusion criteria for this research investigation necessitates that potential participants fall between the ages of 18 and 65. For those younger than 18, there are 54 different clinical trials while 383 exist for individuals exceeding age 65."

Answered by AI

Is there an opportunity to join this medical research program?

"This medical study requires 22 healthy individuals who are aged between 18 and 65. To be eligible, they must have a BMI ranging from 18.0 to 32.0 kg/m^2, as well as weigh at least 50 kilograms and not be of childbearing potential. Furthermore, this trial is open to all genders and races within the specified age range."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
2023. "A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05965570.
~13 spots leftby Apr 2025
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