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

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

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Brensocatib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brensocatib Treatment Sequence ADBC<br>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<br>* Brensocatib oral solutions will be expectorated following the tasting.<br>* Other names: AZD7986;|
| Experimental: Brensocatib Treatment Sequence BACD<br>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<br>* Brensocatib oral solutions will be expectorated following the tasting.<br>* Other names: AZD7986;|
| Experimental: Brensocatib Treatment Sequence CBDA<br>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<br>* Brensocatib oral solutions will be expectorated following the tasting.<br>* Other names: AZD7986;|
| Experimental: Brensocatib Treatment Sequence DCAB<br>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<br>* Brensocatib oral solutions will be expectorated following the tasting.<br>* Other names: AZD7986;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |