Healthy Participants
Conditions
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.
Interventions
DRUGBrensocatib Oral Solution
Brensocatib solution
DRUGBrensocatib Oral Tablet
Brensocatib tablet
Sponsors
Insmed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-dose and at multiple timepoints post-dose on Days 1 and 10 | Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pharmacokinetics of brensocatib following a single administration of different oral formulations in healthy participants will be assessed. |
Countries
United States
Outcome results
None listed