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

NCT05652257 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1007-103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

[14C]-brensocatib

Outcome Measures

Primary Outcomes (6)

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

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

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

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

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

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

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

• Amount Excreted in Urine (Aeu) of Brensocatib

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

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

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

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

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

Secondary Outcomes (2)

• AUC of Brensocatib Metabolites in Plasma

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

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

  Up to Day 14

Study Arms (1)

[14C]-brensocatib

EXPERIMENTAL

Healthy participants will receive single oral dose of \[14C\]-brensocatib on Day 1 under fasted conditions.

Drug: [14C]-brensocatib

Interventions

[14C]-brensocatib DRUG

Oral solution.

[14C]-brensocatib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: August 13, 2021
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)