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The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brensocatib + Clarithromycin | Experimental | Participants will receive a single oral dose of brensocatib in the morning on Days 1 and 13 after an overnight fast, and oral doses of clarithromycin, twice daily (BID), with food on Days 8 to 19. On Day 13, brensocatib will be coadministered with the morning dose of clarithromycin. Clarithromycin can be taken with food, with the exception of the morning dose on the day of coadministration with brensocatib (Day 13), which will be taken after an overnight fast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Oral tablets. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib | The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants. | Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experienced at Least one Adverse Event (AE) | Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants. | Up to Day 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | Oral tablets. |
|
| Organic Chemicals |