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

• Status: Completed
• Trial end date: 2024-01-04
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Insmed Incorporated

Criteria

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.