Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
详细描述
Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential source of lung infection in CF patients. As omadacycline demonstrates antimicrobial activity against a number of pathogens in CF, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with CF in the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with CF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF based on positive sweat chloride or known CF mutation
- •Age >=18 years
排除标准
- •Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs & symptoms and an acute decline in relative FEV1 of 10% or greater.
- •Pregnancy or breastfeeding
- •Serious past allergy to a tetracycline antibiotic
- •No alcohol, nicotine, or caffeine-containing products during the study period
- •Hemoglobin < 8 g/dL
研究组 & 干预措施
Omadacycline IV followed by PO
Omadacycline 100mg IV, Omadacycline 300 mg tablet
干预措施: Omadacycline Injection [Nuzyra] (Drug)
Omadacycline IV followed by PO
Omadacycline 100mg IV, Omadacycline 300 mg tablet
干预措施: Omadacycline Oral Tablet [Nuzyra] (Drug)
结局指标
主要结局
Cmax
时间窗: 3 Days
To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Tmax
时间窗: 3 days
To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
AUC
时间窗: 3 days
To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration.
Absolute Bioavailability
时间窗: 6 days
To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.
次要结局
未报告次要终点
研究者
Paul Beringer
Professor of Clinical Pharmacy
University of Southern California