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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05652257
• Other study ID #: INS1007-103
• Status: Completed
• Phase: Phase 1
• Start date: August 13, 2021
• Est. completion date: September 14, 2021

Study information

• Verified date: March 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.

2. 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:

1. Positive hepatitis panel and/or positive human immunodeficiency virus test. Results consistent with previous vaccination to Hepatitis B are not exclusionary.

2. Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing.

3. Poor peripheral venous access.

4. Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib.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.

5. 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.

6. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-brensocatib
Oral solution.

Locations

Country	Name	City	State
United States	USA001	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AUC8 Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC8 of Plasma Brensocatib Relative to AUC8 of Plasma Total Radioactivity		Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Primary	AUC8 Blood/Plasma Total Radioactivity Ratio Calculated as AUC8 of Whole Blood Total Radioactivity to AUC8 of Plasma Total Radioactivity		Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Primary	Amount Excreted in Urine (Aeu) of Brensocatib		Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Primary	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
Primary	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	AUC of Brensocatib Metabolites in Plasma	Pharmacokinetics of the metabolites following a single dose of brensocatib in healthy participants will be assessed.	Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Secondary	Number of Participants Who Experienced at Least one Adverse Event (AE)	Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.	Up to Day 14