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The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brensocatib Treatment Sequence AB | Experimental | Participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the oral brensocatib tablet (Treatment B). |
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| Brensocatib Treatment Sequence BA | Experimental | Participants will receive a single dose of the oral brensocatib tablet (Treatment B) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib Oral Solution | Drug | Brensocatib solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (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 Days 1 and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experienced at Least one Adverse Event (AE) | Up to Day 23 | |
| Concentration of Brensocatib in Plasma | Pharmacokinetics of brensocatib following a single administration of different oral formulations in healthy participants will be assessed. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Dallas | Texas | 75230 | United States |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
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| Brensocatib Oral Tablet | Drug | Brensocatib tablet |
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| Pre-dose and at multiple timepoints post-dose on Days 1 and 10 |