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The primary purpose of this study is to assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Period 1: Brensocatib | Experimental | Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study. |
|
| Part 1: Period 2: Brensocatib + Rifampin | Experimental | Period 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study. |
|
| Part 2: Period 1: Brensocatib | Experimental | Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study. |
|
| Part 2: Period 2: Brensocatib + Esomeprazole | Experimental | Period 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Area Under the Concentration-time (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 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE) | Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants. | Up to Day 31 (Part 1) and up to Day 26 (Part 2) |
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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 | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
| D012293 | Rifampin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug | Oral capsules. |
|
| Esomeprazole | Drug | Oral capsules. |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |