A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Brensocatib
* Drug: Rifampin
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants defined by no significant other conditions as in the protocol. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, or psychiatric disorder, as determined by the investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee). Note: Other inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Period 1: Brensocatib<br>Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study. | Drug: Brensocatib<br>* Oral tablets.<br>* Other names: INS1007;|
| Experimental: Part 1: Period 2: Brensocatib + Rifampin<br>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. | Drug: Brensocatib<br>* Oral tablets.<br>* Other names: INS1007;Drug: Rifampin<br>* Oral capsules.<br>|
| Experimental: Part 2: Period 1: Brensocatib<br>Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study. | Drug: Brensocatib<br>* Oral tablets.<br>* Other names: INS1007;|
| Experimental: Part 2: Period 2: Brensocatib + Esomeprazole<br>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. | Drug: Brensocatib<br>* Oral tablets.<br>* Other names: INS1007;Drug: Esomeprazole<br>* Oral capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brensocatib, INS1007