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

NCT06178783 | Completed Phase 1 FDA Drug

• 2 other identifiers: INS1007-1078521537
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic Scale

  Day 1

Secondary Outcomes (1)

• Number of Participants who Experienced at Least one Adverse Event (AE)

  Up to Day 4

Study Arms (4)

Brensocatib Treatment Sequence ADBC

EXPERIMENTAL

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

Brensocatib Treatment Sequence BACD

EXPERIMENTAL

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

Brensocatib Treatment Sequence CBDA

EXPERIMENTAL

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

Brensocatib Treatment Sequence DCAB

EXPERIMENTAL

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

Interventions

Brensocatib DRUG

Brensocatib oral solutions will be expectorated following the tasting.

Also known as: INS1007, AZD7986

Brensocatib Treatment Sequence ADBC; Brensocatib Treatment Sequence BACD; Brensocatib Treatment Sequence CBDA; Brensocatib Treatment Sequence DCAB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

brensocatib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: December 27, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)