A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178783
• Other study ID #: INS1007-107
• Secondary ID: 8521537
• Status: Completed
• Phase: Phase 1
• Start date: December 27, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Brensocatib
Brensocatib oral solutions will be expectorated following the tasting.

Locations

Country	Name	City	State
United States	USA001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic Scale		Day 1
Secondary	Number of Participants who Experienced at Least one Adverse Event (AE)	Determination of the tolerability of brensocatib oral solutions in healthy participants.	Up to Day 4