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

Insmed

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Brensocatib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06178783

INS1007-107

8521537 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

Brensocatib Treatment Sequence ADBC

Experimental group

Description:

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.

Treatment:

Drug: Brensocatib

Brensocatib Treatment Sequence BACD

Experimental group

Description:

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.

Treatment:

Drug: Brensocatib

Brensocatib Treatment Sequence CBDA

Experimental group

Description:

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.

Treatment:

Drug: Brensocatib

Brensocatib Treatment Sequence DCAB

Experimental group

Description:

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.

Treatment:

Drug: Brensocatib