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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-brensocatib | Experimental | Healthy participants will receive single oral dose of [14C]-brensocatib on Day 1 under fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-brensocatib | Drug | Oral solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity | 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 | Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14 | |
| Amount Excreted in Urine (Aeu) of Brensocatib | 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 | 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) | Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants Who Experienced at Least one Adverse Event (AE) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Madison | Wisconsin | 53704 | United States |
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Safety and tolerability of a single dose of brensocatib will be determined in healthy participants. |
| Up to Day 14 |