A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet
研究概览
简要总结
This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Must agree to adhere to the protocol-specified contraception requirements.
- •Body mass index of 18.0 to 32.0 kilograms (kg)/meter squared as measured at screening.
- •Weight ≥50 kg at screening.
排除标准
- •Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.
- •History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.
- •Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold.
- •Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.
- •Participants who do not agree to eat a high-fat breakfast.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Regimen C: Delafloxacin Powder
Participants will receive delafloxacin powder in fasted or fed states.
干预措施: Delafloxacin Powder (Drug)
Regimen B then A: Delafloxacin Powder then Tablet
Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
干预措施: Delafloxacin Powder (Drug)
Regimen D (Optional): Delafloxacin Powder
Participants will receive delafloxacin powder in fasted or fed states.
干预措施: Delafloxacin Powder (Drug)
Regimen A then B: Delafloxacin Tablet then Powder
Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
干预措施: Delafloxacin (Drug)
Regimen A then B: Delafloxacin Tablet then Powder
Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
干预措施: Delafloxacin Powder (Drug)
Regimen B then A: Delafloxacin Powder then Tablet
Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
干预措施: Delafloxacin (Drug)
结局指标
主要结局
Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet
时间窗: Pre-dose on Day 1, up to 24 hours post-dose
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
次要结局
- Maximum Observed Concentration (Cmax) of Delafloxacin Powder(Pre-dose on Day 1, up to 48 hours post-dose)
- Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder(Pre-dose on Day 1, up to 48 hours post-dose)
- Number of Participants Experiencing Treatment-emergent Adverse Events(Day 1 through Day 6)