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Anti-inflammatory

Brensocatib Treatment Sequence AB for Healthy Subjects (INS1007 Trial)

Phase 1

Recruiting

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 and 10

Awards & highlights

INS1007 Trial Summary

"This trial is trying to figure out how well the body absorbs brensocatib in children by comparing an oral solution and tablets in healthy kids."

Who is the study for?

This trial is for healthy adults who are non-smokers, have not used chewing tobacco in the last 3 months, and have a BMI between 18.0-32.0 with a weight of at least 50 kg. Women must be postmenopausal, surgically sterile or using effective contraception; men also need to use reliable contraception.Check my eligibility

What is being tested?

The study aims to compare how the body absorbs brensocatib when taken as an oral solution versus as a tablet in healthy individuals. It's designed to see if there's any difference in the way these two forms deliver medication into the bloodstream.See study design

What are the potential side effects?

Since this trial involves healthy participants and focuses on bioavailability rather than treatment effects, specific side effects are not detailed but may include typical drug-related reactions such as digestive discomfort or allergic responses.

INS1007 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and at multiple timepoints post-dose on days 1 and 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 and 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma

Secondary outcome measures

Concentration of Brensocatib in Plasma

Number of Participants who Experienced at Least one Adverse Event (AE)

INS1007 Trial Design

2Treatment groups

Experimental Treatment

Group I: Brensocatib Treatment Sequence BAExperimental Treatment2 Interventions

Participants will receive a single dose of the oral brensocatib tablet (Treatment B) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A).

Group II: Brensocatib Treatment Sequence ABExperimental Treatment2 Interventions

Participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the oral brensocatib tablet (Treatment B).

Do I qualify?Apply below to find out

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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

7,178 Total Patients Enrolled

Frequently Asked Questions

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

Can individuals above the age of 40 participate in this research study?

"This research study includes individuals between 18 and 65 years old. There are a total of 70 trials available for participants under 18, while there are 395 trials open to those over the age of 65."

Answered by AI

May I inquire about the criteria for potential participation in this medical study?

"To be eligible for this research, individuals must be in good health and between 18 and 65 years old. The study aims to enroll a total of 24 participants."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this research project is currently seeking eligible individuals. The trial was initially disclosed on April 30th, 2024, and its latest revision was made on April 8th of the same year."

Answered by AI

What is the upper limit for the number of individuals enrolled in this clinical investigation?

"Indeed, information from clinicaltrials.gov reveals that this investigation is actively seeking volunteers. The study was first listed on April 30th, 2024 and was last modified on April 8th, 2024. Enrollment aims to recruit a total of 24 participants from one designated site."

Answered by AI

Has the treatment sequence BA for Brensocatib been officially approved by the FDA?

"Given the early stage of this trial, Brensocatib Treatment Sequence BA has been rated as a 1 for safety by our team at Power. This Phase 1 study currently lacks extensive data supporting its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants

2024. "A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06344728.

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