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

Sponsor

Insmed Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT05652257

Collaborator

(none)

Enrollment

Location

Arm

1.1

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]-brensocatib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Aug 13, 2021

Actual Primary Completion Date :

Sep 14, 2021

Actual Study Completion Date :

Sep 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]-brensocatib Healthy participants will receive single oral dose of [14C]-brensocatib on Day 1 under fasted conditions.	Drug: [14C]-brensocatib Oral solution.

Arm

Intervention/Treatment

Experimental: [14C]-brensocatib

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

Drug: [14C]-brensocatib

Oral solution.

Outcome Measures

Primary Outcome Measures

Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma [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.
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 Outcome Measures

AUC of Brensocatib Metabolites in Plasma [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.
Number of Participants Who Experienced at Least one Adverse Event (AE) [Up to Day 14]
Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USA001	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Insmed Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Insmed Incorporated

ClinicalTrials.gov Identifier:

NCT05652257

Other Study ID Numbers:

INS1007-103

First Posted:

Dec 15, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Insmed Incorporated

[14C]-brensocatib

Study Results

No Results Posted as of Dec 15, 2022