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Anti-inflammatory

Part 2: Period 2: Brensocatib + Esomeprazole 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and at multiple timepoints post-dose on days 1 to 7, 17 (part 1), and days 1 to 7, 12 to 18 (part 2)
Awards & highlights

Study Summary

This trial will study how medications interact with a new drug, brensocatib, to see if it's effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 7, 17 (part 1), and days 1 to 7, 12 to 18 (part 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 7, 17 (part 1), and days 1 to 7, 12 to 18 (part 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
Secondary outcome measures
Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2: Period 2: Brensocatib + EsomeprazoleExperimental Treatment2 Interventions
Period 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study.
Group II: Part 2: Period 1: BrensocatibExperimental Treatment1 Intervention
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study.
Group III: Part 1: Period 2: Brensocatib + RifampinExperimental Treatment2 Interventions
Period 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study.
Group IV: Part 1: Period 1: BrensocatibExperimental Treatment1 Intervention
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifampin
2011
Completed Phase 3
~2140
Brensocatib
2023
Completed Phase 3
~620
Esomeprazole
2008
Completed Phase 4
~2670

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
7,170 Total Patients Enrolled

Frequently Asked Questions

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

Are there vacancies in this trial available for enrollees?

"Affirmative, clinicaltrials.gov divulges that this experiment is actively enrolling volunteers. The trial commenced on May 10th 2023 and was last revised on the 5th of May 2023; 32 patient participants are sought from a single medical facility."

Answered by AI

Are geriatric individuals being considered for participation in this investigation?

"As delineated by the study's requirements, patients must be between 18 and 55 years old to take part."

Answered by AI

May I partake in this research project given my qualifications?

"To gain admittance to this clinical trial, applicants must meet the criteria of being aged between 18 and 55 years old. Additionally, prospective participants should be in robust health. As such, 32 people are needed for this medical research."

Answered by AI

How many individuals are currently participating in this experiment?

"Confirmed, the clinicaltrials.gov resource shows that this research is currently enrolling participants. It was initally posted on May 10th 2023 and its most recent update occured on May 5th 2023. This study requires 32 patients to be recruited from one site of recruitment."

Answered by AI

How secure is the combination of Brensocatib and Rifampin during period two?

"The safety of the Part 1: Period 2: Brensocatib + Rifampin combination was rated a 1, as there is only limited evidence to support its efficacy and safety from Phase 1 trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
USA001
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
2023. "A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05826574.
~17 spots leftby Apr 2025
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