Healthy Volunteers
Conditions
Brief summary
The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.
Interventions
DRUGBrensocatib
Brensocatib oral solutions will be expectorated following the tasting.
Sponsors
Insmed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kilogram per meter square (kg/m\^2), inclusive, and a body weight of ≥50 kilograms (kg) at screening. * In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable), and physical examination at screening and/or Day 1, as assessed by the investigator (or designee). * Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Exclusion criteria
* Positive hepatitis panel and/or positive human immunodeficiency virus test. * The participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease. * The participant is unable to taste and smell normally, to his/her own opinion, at any time throughout the study duration Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or continue the study. * Administration of a vaccine in the past 14 days prior to Day 1. * 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 Day 1, whichever is longer. * History of alcoholism or drug/chemical abuse within 2 years prior to Day 1. * Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. * Poor peripheral venous access. Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic Scale | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experienced at Least one Adverse Event (AE) | Up to Day 4 | Determination of the tolerability of brensocatib oral solutions in healthy participants. |
Countries
United States
Outcome results
None listed