Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 31
- 主要终点
- Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its Metabolites
研究概览
简要总结
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ages 3 months through 14 years inclusive
- •Receiving antibiotics for suspected or proven infection
排除标准
- •Body weight greater than 45 kg
- •Patients taking anti-seizure medications within 30 days of moxifloxacin dosing
- •Known or suspected allergy to quinolones
- •History of tendon disease/disorder related to quinolone treatment
- •Severe, life-threatening disease with a life expectancy of less than 48 hours and/or known rapidly fatal underlying disease (death expected within 2 months)
- •Abnormal musculoskeletal evaluation at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
- •Cardiac arrhythmia
- •Evidence of renal or hepatic disease, based on laboratory findings (serum creatinine, total bilirubin, or ALT, > 1.5 times upper limit of normal) and physical exam
- •Patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents
- •Patients taking any medication known to increase the QT interval, eg, amiodarone, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, disopyuramide, dofetilide, droperidol, halofantrine, haloperidol, ibutilide, levomethadyl, mesoradazine, methadone, pimozide, procainamide, quinidine, sotalol, terfenadine
- •Pregnancy
- •Clinically relevant findings in the ECG
- •Participation in another clinical study during the preceding 30 days1 (last treatment from previous study to first treatment of new study)
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
- •Patients taking another fluoroquinolone at the time of planned moxifloxacin dosing
研究组 & 干预措施
Moxifloxacin (Avelox, BAY12-8039), Cohort 1
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Moxifloxacin (Avelox, BAY12-8039), Cohort 2
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Moxifloxacin (Avelox, BAY12-8039), Cohort 3
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
结局指标
主要结局
Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its Metabolites
时间窗: Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Maximum Observed Drug Concentration in Plasma (Cmax) of Moxifloxacin and its Metabolites
时间窗: Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Number of Subjects With Treatment Emergent Findings on Joint Assessment: Baseline
时间窗: Baseline
Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. All joints were examined for pain/tenderness, evidence of inflammation (i.e., redness, warmth, deformity, swelling or ballotable fluid), loss of function (to the extent this could be assessed in younger children and infants), and any restrictions to expected active/passive range of motion. An incidence count was reported as the number of subjects with at least one finding at baseline, regardless of side.
Number of Subjects With Treatment Emergent Findings on Joint Assessment : At any Time During Treatment
时间窗: Day 1 up to Year 5 (follow-up)
Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. An incidence count was reported as the number of subjects with at least one finding at any time during treatment, regardless of side.
次要结局
- Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))
- Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))
- Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its Metabolites(Baseline up to 36 hour post-infusion)
- Volume of Distribution at Steady State (Vss) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))
- Plasma Clearance (CL) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kilogram Body Weight (AUCnorm) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))
- Maximum Observed Plasma Concentration Divided by Dose Per kilogram Body Weight (Cmax,Norm) of Moxifloxacin and its Metabolites(Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional))