A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05826574
- Lead Sponsor
- Insmed Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Period 1: Brensocatib Brensocatib 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 Brensocatib 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 1: Period 2: Brensocatib + Rifampin Rifampin 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 Brensocatib 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 Brensocatib 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. Part 2: Period 2: Brensocatib + Esomeprazole Esomeprazole 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.
- Primary Outcome Measures
Name Time Method Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma 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) Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE) Up to Day 31 (Part 1) and up to Day 26 (Part 2) Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.
Trial Locations
- Locations (1)
USA001
🇺🇸Dallas, Texas, United States