A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
- Registration Number
- NCT06178783
- Lead Sponsor
- Insmed Incorporated
- Brief Summary
The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Brensocatib Treatment Sequence CBDA Brensocatib 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. Brensocatib Treatment Sequence ADBC Brensocatib 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. Brensocatib Treatment Sequence BACD Brensocatib 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. Brensocatib Treatment Sequence DCAB Brensocatib 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of Participants who Experienced at Least one Adverse Event (AE) Up to Day 4 Determination of the tolerability of brensocatib oral solutions in healthy participants.
Trial Locations
- Locations (1)
USA001
🇺🇸Dallas, Texas, United States