Brensocatib for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
USA001, Madison, WI
Healthy Subjects (HS)
Brensocatib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic dose of brensocatib to be used in Part 2 of the study. The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT interval.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

Day 35
Part 2: Number of Participants who Experienced at least one TEAE
Day 1
Parts 1 and 2: AUC From Time Zero Extrapolated to Infinity (AUC∞) of Brensocatib
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUCtlast) of Brensocatib
Parts 1 and 2: Elimination Half-Life (t1/2) of Brensocatib
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Parts 1 and 2: Time to Maximum Observed Plasma Concentration (Tmax) of Brensocatib
Parts 1 and 2: Total Clearance of Brensocatib Following Extravascular Administration (CL/F)
Parts 1 and 2: Volume of Distribution of Brensocatib Following Extravascular Administration (Vz/F)
Day 28
Parts 1 and 2: Number of Participants who Experienced at least one Treatment-Emergent Adverse Events (TEAEs) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Day 1
Part 2: Number of Participants With Categorical Outliers for ECG Parameters: HR, PR, QRS, and QTcF
Part 2: Placebo- and Baseline-Corrected QTcF (ΔΔQTcF)
Parts 2: Change From Baseline in QTcF (ΔQTcF) Interval
Up to Day 7
Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

3 Treatment Groups

Part 1: Treatment Dose 2
1 of 3
Part 2
1 of 3
Part 1: Treatment Dose 1
1 of 3
Experimental Treatment

48 Total Participants · 3 Treatment Groups

Primary Treatment: Brensocatib · Has Placebo Group · Phase 1

Part 1: Treatment Dose 2Experimental Group · 2 Interventions: Brensocatib, Placebo · Intervention Types: Drug, Drug
Part 2Experimental Group · 3 Interventions: Brensocatib, Moxifloxacin, Placebo · Intervention Types: Drug, Drug, Drug
Part 1: Treatment Dose 1Experimental Group · 2 Interventions: Brensocatib, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2020
Completed Phase 3
~410
Moxifloxacin
2013
Completed Phase 4
~3290
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: part 1: pre-dose and at multiple timepoints post-dose on days 1 to 4; part 2: pre-dose and at multiple timepoints post-dose on days 1 to 4 in each period
Closest Location: USA001 · Madison, WI
Photo of madison 1Photo of madison 2Photo of madison 3
2022First Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
3 CompletedClinical Trials

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
27 Previous Clinical Trials
4,313 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and will not be pregnant or lactating, and you and your partner agree to use contraception.
You are able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.