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

A Phase 1, Double-blind, Randomized, Single-center Study to Assess the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Brensocatib

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Insmed Medical Information; Phone Number: 1-844-446-7633; Email: medicalinformation@insmed.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • USA001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brensocatib Treatment Sequence ADBC; Participants will taste and expectorate Dose 1 of each brensocatib formulation across the 4 treatment administrations (Treatments A, B, C, and D), orally on Day 1 in the sequence ADBC.	Drug: Brensocatib; Brensocatib oral solutions will be expectorated following the tasting.; Other Names: INS1007; AZD7986
Experimental: Brensocatib Treatment Sequence BACD; Participants will taste and expectorate Dose 1 of each brensocatib formulation across the 4 treatment administrations (Treatments A, B, C, and D), orally on Day 1 in the sequence BACD.	Drug: Brensocatib; Brensocatib oral solutions will be expectorated following the tasting.; Other Names: INS1007; AZD7986
Experimental: Brensocatib Treatment Sequence CBDA; Participants will taste and expectorate Dose 1 of each brensocatib formulation across the 4 treatment administrations (Treatments A, B, C, and D), orally on Day 1 in the sequence CBDA.	Drug: Brensocatib; Brensocatib oral solutions will be expectorated following the tasting.; Other Names: INS1007; AZD7986
Experimental: Brensocatib Treatment Sequence DCAB; Participants will taste and expectorate Dose 1 of each brensocatib formulation across the 4 treatment administrations (Treatments A, B, C, and D), orally on Day 1 in the sequence DCAB.	Drug: Brensocatib; Brensocatib oral solutions will be expectorated following the tasting.; Other Names: INS1007; AZD7986

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Insmed Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: INS1007-107; 8521537 (Other Identifier: Fortrea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No