NCT01290900已完成1 期
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of a Single Dose of Intravenous Ceftazidime NXL104 (3000/2000 mg) or Ceftaroline Fosamil NXL104 (1500/2000 mg), Compared With Placebo, Using Open-label Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF).
研究概览
简要总结
This is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed informed consent prior to any study specific procedures
- •Healthy male volunteers aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venepuncture
- •Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg
- •Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for more than 3 months prior to the start of the study
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- •Any clinically significant abnormalities in physical examination, clinical chemistry, haematology or urinalysis results as judged by the Investigator
- •Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: Systolic blood pressure (SBP) greater than 140 mmHg, Diastolic blood pressure (DBP) greater than 90 mmHg, Heart rate less than 40 or greater than 85 beats per minute - at Visit 1
- •Prolonged QTcF >450 ms or shortened QTcF <340 ms
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes volunteers with any of the following: Clinically significant PR (PQ) interval prolongation, Intermittent second or third degree AV block (Mobitz II type 1, Wenchebach during sleep is not disqualifying), Incomplete, full or intermittent bundle branch block (QRS less than 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy), Abnormal T wave morphology, particularly in the protocol defined primary lead
研究组 & 干预措施
CXL104
Experimental
2000 mg NXL104 + 1500 mg Ceftaroline (IV)
干预措施: NXL104 (Drug)
CXL104
Experimental
2000 mg NXL104 + 1500 mg Ceftaroline (IV)
干预措施: Ceftaroline (Drug)
CAZ104
Experimental
Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)
干预措施: NXL104 (Drug)
CAZ104
Experimental
Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)
干预措施: Placebo Infusion (Drug)
CAZ104
Experimental
Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)
干预措施: Ceftazidime (Drug)
Moxifloxacin
Active Comparator
Moxifloxacin 400mg (1 tablet)
干预措施: Moxifloxacin (Drug)
Placebo
Placebo Comparator
Placebo Infusion (saline)
干预措施: Placebo Infusion (Drug)
结局指标
主要结局
To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF).
时间窗: 12-lead dECG at 24 hour after starting dosing.
次要结局
- To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB).(12-lead dECG at 24 hour after starting dosing.)
- To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F.(Blood samples will be taken at 24 hour after starting dosing.)
研究者
研究点 (1)
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