USA001
Madison, Wisconsin, 53704, United States
NCT Number: NCT05652257
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other inclusion/exclusion criteria may apply.
Oral solution.
Time frame: 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.
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Time frame: 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.
Time frame: Up to Day 14
Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.
Insmed Incorporated
Industry
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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