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Completed

NCT Number: NCT06178783

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brensocatib

Drug

Brensocatib oral solutions will be expectorated following the tasting.

Other names: INS1007, AZD7986

Primary outcomes

  1. Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic Scale

    Time frame: Day 1

Secondary outcomes

  1. Number of Participants who Experienced at Least one Adverse Event (AE)

    Time frame: Up to Day 4

    Determination of the tolerability of brensocatib oral solutions in healthy participants.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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