A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib
研究概览
简要总结
The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of nonchildbearing potential and males, of any race, between 18 and 65 years of age, inclusive, without current disease.
- •Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg).
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, 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, unless approved by the investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- •Positive serology test results for hepatitis B panel or hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test.
- •Participants whose results are compatible with prior immunization for hepatitis B or natural immunity may be included at the discretion of the investigator.
- •Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or check-in.
- •Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Brensocatib + Clarithromycin
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.
干预措施: Brensocatib (Drug)
Brensocatib + Clarithromycin
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.
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20
The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants.
次要结局
- Number of Participants who Experienced at Least one Adverse Event (AE)(Up to Day 27)