A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
- •BMI between 18.0-30.0 kg/m2
- •Creatinine clearance estimated by Cockroft Gault formula > 80 mL/min and < 160 ml/min (for males), or < 150ml/min (females)
- •Non smokers
- •Normal audiogram.
排除标准
- •History or suspicion of alcohol and/or drug abuse in the last 5 years
- •Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
- •Regular consumption of large amounts of xanthine
- •Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
- •Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- •Any signs of renal impairment
- •Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
- •Clinically significant abnormal ECG
研究组 & 干预措施
Treatment sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: POL7080 (Drug)
Treatment sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: Amikacin (Drug)
Treatment sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: POL7080 + Amikacin (Drug)
Treatment sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: POL7080 (Drug)
Treatment sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: Amikacin (Drug)
Treatment sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment.
干预措施: POL7080 + Amikacin (Drug)
结局指标
主要结局
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
时间窗: Up to 4 days for each period
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
时间窗: Up to 4 days for each period
次要结局
- Incidence of adverse Events(up to 19 days)