Clinical trial NCT06178783: A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
Official title: A Phase 1, Double-blind, Randomized, Single-center Study to Assess the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-12-21
Enrollment: 20
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 assess the palatability and compare acceptability of brensocatib oral solutions.


Eligibility criteria: 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/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic Scale
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants who Experienced at Least one Adverse Event (AE)
timeFrame: Up to Day 4
Other outcomes:
Locations:
city: Dallas
country: United States
facility: USA001
state: Texas
Study officials:
References: