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

NCT ID: NCT06344728

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-05-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Brensocatib Oral Solution

Intervention Type: DRUG

Brensocatib solution

Brensocatib Oral Tablet

Intervention Type: DRUG

Brensocatib tablet

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).

Group Type: EXPERIMENTAL

Brensocatib Oral Solution

Intervention Type: DRUG

Brensocatib solution

Brensocatib Oral Tablet

Intervention Type: DRUG

Brensocatib tablet

Interventions

Brensocatib Oral Solution

Brensocatib solution

Intervention Type: DRUG

Brensocatib Oral Tablet

Brensocatib tablet

Intervention Type: DRUG

Other Intervention Names

INS1007; INS1007

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Dallas, Texas, United States

Countries

United States

Other Identifiers

INS1007-110

Identifier Type: -

Identifier Source: org_study_id