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

NCT ID: NCT06178783

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2024-01-04

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Brensocatib Treatment Sequence ADBC

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.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Brensocatib oral solutions will be expectorated following the tasting.

Brensocatib Treatment Sequence BACD

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.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Brensocatib oral solutions will be expectorated following the tasting.

Brensocatib Treatment Sequence CBDA

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.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Brensocatib oral solutions will be expectorated following the tasting.

Brensocatib Treatment Sequence DCAB

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.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Brensocatib oral solutions will be expectorated following the tasting.

Interventions

Brensocatib

Brensocatib oral solutions will be expectorated following the tasting.

Intervention Type: DRUG

Other Intervention Names

INS1007; AZD7986

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Dallas, Texas, United States

Countries

United States

Other Identifiers

8521537

Identifier Type: OTHER

Identifier Source: secondary_id

INS1007-107

Identifier Type: -

Identifier Source: org_study_id