Status:
COMPLETED
A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
Lead Sponsor:
Insmed Incorporated
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06178783
Start Date
December 27 2023
End Date
January 4 2024
Last Update
January 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
USA001
Dallas, Texas, United States, 75247