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Completed

NCT Number: NCT06344728

A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants

The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Dallas, Texas, 75230, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Body mass index between 18.0 and 32.0 kilogram per square meter (kg/m^2), and a body weight of ≥ 50 kilogram (kg) at Screening.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test at Screening and Day -1 and agree to contraceptive requirements.
  • To be a non-smoker and has not used chewing tobacco for at least 3 months prior to screening.
  • Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception from Screening to at least 30 days after discharge.
  • Male participants must be on a stable method of contraception starting at Screening and continuing to at least 30 days after discharge.

Key Exclusion Criteria:

  • History of stomach, gall bladder, or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
  • Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to first dose.
  • Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dose.
  • 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 first dose, whichever is longer.
  • History of alcoholism or drug abuse within 2 years prior to check-in or 3 months before Screening, or excessive alcohol consumption (regular alcohol intake > 21 units per week for male participants and > 14 units of alcohol per week for female participants) (1 unit is equal to approximately 0.5 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
  • Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.

Treatment and study plan

Brensocatib Oral Solution

Drug

Brensocatib solution

Other names: INS1007

Brensocatib Oral Tablet

Drug

Brensocatib tablet

Other names: INS1007

Primary outcomes

  1. Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10

    Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.

Secondary outcomes

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

    Time frame: Up to Day 23

  2. Concentration of Brensocatib in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10

    Pharmacokinetics of brensocatib following a single administration of different oral formulations in healthy participants will be assessed.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Two-Period Crossover Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets Following Single Oral Doses in Healthy Subjects

Acronym: INS1007

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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