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

NCT ID: NCT05652257

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2021-09-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]-brensocatib

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

Group Type: EXPERIMENTAL

[14C]-brensocatib

Intervention Type: DRUG

Oral solution.

Interventions

[14C]-brensocatib

Oral solution.

Intervention Type: DRUG

Eligibility Criteria

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 Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib.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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

INS1007-103

Identifier Type: -

Identifier Source: org_study_id