A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants (INS1007)

A Phase 1, Open-Label, Randomized, Two-Period Crossover Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets Following Single Oral Doses in Healthy Subjects

The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Brensocatib Oral Solution; Drug: Brensocatib Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Insmed Medical Information; Phone Number: 1-844-446-7633; Email: medicalinformation@insmed.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • USA001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Body mass index between 18.0 and 32.0 kilogram per square meter (kg/m^2), and a body weight of ≥ 50 kilogram (kg) at Screening.
• Female participants of childbearing potential must have a negative urine or serum pregnancy test at Screening and Day -1 and agree to contraceptive requirements.
• To be a non-smoker and has not used chewing tobacco for at least 3 months prior to screening.
• Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception from Screening to at least 30 days after discharge.
• Male participants must be on a stable method of contraception starting at Screening and continuing to at least 30 days after discharge.

Key Exclusion Criteria:

• History of stomach, gall bladder, or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to first dose.
• Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dose.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 60 days or 5 half-lives of that drug prior to first dose, whichever is longer.
• History of alcoholism or drug abuse within 2 years prior to check-in or 3 months before Screening, or excessive alcohol consumption (regular alcohol intake > 21 units per week for male participants and > 14 units of alcohol per week for female participants) (1 unit is equal to approximately 0.5 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
• Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brensocatib Treatment Sequence AB; 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).	Drug: Brensocatib Oral Solution; Brensocatib solution; Other Names: INS1007; Drug: Brensocatib Oral Tablet; Brensocatib tablet; Other Names: INS1007
Experimental: Brensocatib Treatment Sequence BA; 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).	Drug: Brensocatib Oral Solution; Brensocatib solution; Other Names: INS1007; Drug: Brensocatib Oral Tablet; Brensocatib tablet; Other Names: INS1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.	Pre-dose and at multiple timepoints post-dose on Days 1 and 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who Experienced at Least one Adverse Event (AE)		Up to Day 23
Concentration of Brensocatib in Plasma	Pharmacokinetics of brensocatib following a single administration of different oral formulations in healthy participants will be assessed.	Pre-dose and at multiple timepoints post-dose on Days 1 and 10

Collaborators and Investigators

• Sponsor: Insmed Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): May 21, 2024
• Study Completion (Estimated): May 21, 2024

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: INS1007-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No