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Completed

NCT Number: NCT05652257

A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants

The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of [14C]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).

Exclusion criteria

  • Positive hepatitis panel and/or positive human immunodeficiency virus test. Results consistent with previous vaccination to Hepatitis B are not exclusionary.
  • Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing.
  • Poor peripheral venous access.
  • Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib. Known allergy to brensocatib or any of the excipients used in the formulation.
  • Exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
  • Participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator).

Note: Other inclusion/exclusion criteria may apply.

Treatment and study plan

[14C]-brensocatib

Drug

Oral solution.

Primary outcomes

  1. Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

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

  2. AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

  3. AUC∞ Blood/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Whole Blood Total Radioactivity to AUC∞ of Plasma Total Radioactivity

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

  4. Amount Excreted in Urine (Aeu) of Brensocatib

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

  5. Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Urine

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

  6. Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Feces (Aef)

    Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14

Secondary outcomes

  1. AUC of Brensocatib Metabolites in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9

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

  2. Number of Participants Who Experienced at Least one Adverse Event (AE)

    Time frame: Up to Day 14

    Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2022
Registry last updated
Mar 23, 2023

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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