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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Oral solution.
USA001
Madison, Wisconsin, United States
Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
Time frame: 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
Time frame: 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
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Amount Excreted in Urine (Aeu) of Brensocatib
Time frame: 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
Time frame: 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)
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
AUC of Brensocatib Metabolites in Plasma
Pharmacokinetics of the metabolites following a single dose of brensocatib in healthy participants will be assessed.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Number of Participants Who Experienced at Least one Adverse Event (AE)
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Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.
Time frame: Up to Day 14