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

NCT06344728 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1007-110
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Up to Day 23

• Concentration of Brensocatib in Plasma

  Pre-dose and at multiple timepoints post-dose on Days 1 and 10

Study Arms (2)

Brensocatib Treatment Sequence AB

EXPERIMENTAL

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; Drug: Brensocatib Oral Tablet

Brensocatib Treatment Sequence BA

EXPERIMENTAL

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; Drug: Brensocatib Oral Tablet

Interventions

Brensocatib Oral Solution DRUG

Brensocatib solution

Also known as: INS1007

Brensocatib Treatment Sequence AB; Brensocatib Treatment Sequence BA

Brensocatib Oral Tablet DRUG

Brensocatib tablet

Also known as: INS1007

Brensocatib Treatment Sequence AB; Brensocatib Treatment Sequence BA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Dallas, Texas, 75230, United States

Location

MeSH Terms

Interventions

brensocatib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 30, 2024
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)