Clinical trial NCT05652257: A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: [14C]-brensocatib
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib.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

Note: Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
measure: AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
measure: AUC∞ Blood/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Whole Blood Total Radioactivity to AUC∞ of Plasma Total Radioactivity
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
measure: Amount Excreted in Urine (Aeu) of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
measure: Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Urine
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
measure: Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Feces (Aef)
timeFrame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Secondary outcomes:
measure: AUC of Brensocatib Metabolites in Plasma
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
measure: Number of Participants Who Experienced at Least one Adverse Event (AE)
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: Madison
country: United States
facility: USA001
state: Wisconsin
Study officials:
References: