Clinical trial NCT06344728: A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10
Secondary outcomes:
measure: Number of Participants who Experienced at Least one Adverse Event (AE)
timeFrame: Up to Day 23
measure: Concentration of Brensocatib in Plasma
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10
Other outcomes:
Locations:
city: Dallas
country: United States
facility: USA001
state: Texas
Study officials:
References: