NCT02176005已完成1 期
Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy 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
- Da Volterra
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)
研究概览
简要总结
The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
详细描述
The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:
- To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
- To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.
In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.
The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Normal digestive transit, with usually one daily stool.
- •Females participating in the study :
- •must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.
- •Having given and signed the written study informed consent prior to undertaking any study-related procedure.
- •Covered by the French Health Insurance system.
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
- •Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
- •Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
- •Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
- •Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
- •Fecal colonisation by Clostridium difficile.
- •Recent history of hospitalisation (within 3 months prior to inclusion).
- •Any antibiotic administration within 3 months before inclusion.
- •Any vaccination within the last 28 days.
研究组 & 干预措施
Moxifloxacin
Active Comparator
Moxifloxacin, oral tablets, 400mg/day, once daily 5 days
干预措施: Moxifloxacin (Drug)
moxifloxacin + DAV132
Experimental
Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days
干预措施: DAV132 (Device)
moxifloxacin + DAV132
Experimental
Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days
干预措施: Moxifloxacin (Drug)
DAV132
Experimental
DAV132 oral, 7.5g x3/day for 7 days
干预措施: DAV132 (Device)
Negative control
Placebo Comparator
Negative control: 7.5g x3/day for 7 days
干预措施: Negative Control (Other)
结局指标
主要结局
Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)
时间窗: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16
次要结局
- Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5(D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose)
- Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1(D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose)
- Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5(D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose)
- Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product(From randomization to 37 days after the beginning of treatment)
- Percentage of Subjects With Adverse Events Related to Study Product(From randomization to 37 days after the beginning of treatment)
- Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)(D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37)
- Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1(D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose)
研究者
研究点 (1)
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