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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants defined by no significant other conditions as in the protocol.
排除标准
- •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.
研究组 & 干预措施
Part 1: Period 1: Brensocatib
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study.
干预措施: Brensocatib (Drug)
Part 1: Period 2: Brensocatib + 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.
干预措施: Brensocatib (Drug)
Part 1: Period 2: Brensocatib + 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.
干预措施: Rifampin (Drug)
Part 2: Period 1: Brensocatib
Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study.
干预措施: Brensocatib (Drug)
Part 2: Period 2: Brensocatib + 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.
干预措施: Brensocatib (Drug)
Part 2: Period 2: Brensocatib + 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.
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
时间窗: 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.
次要结局
- 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))