A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse events will be monitored as a measure of safety and tolerability
研究概览
简要总结
This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be considered as 'Japanese', both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for more than 5 years
- •Have a body mass index (BMI) between 17 and 27 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg.
- •Females must not be lactating, and must be of non-childbearing potential (post-menopausal at least 12 months or documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
排除标准
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •Symptoms of a clinically significant illness in the 3 months before the study
- •History of hypersensitivity (eg, anaphylaxis), serious allergy, or any serious reaction to carbapenem, cephalosporins, or other β-lactam antibiotics
- •Use within 14 days prior to the first study dose of any over-the-counter (including St. John's Wort or any herbal products) or prescription medication
- •Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months
研究组 & 干预措施
Placebo
Three Japanese subjects to receive placebo IV doses
干预措施: Placebo (Drug)
NXL104
Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
干预措施: NXL104 (Drug)
Ceftazidime NXL104 (CAZ104)
Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
干预措施: CAZ104 (Drug)
结局指标
主要结局
Adverse events will be monitored as a measure of safety and tolerability
时间窗: A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
时间窗: A range of 12 days
次要结局
- The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime(Range of 8 days)
- The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime(Range of 8 days)
- The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime(Range of 12 days)