NCT02184091已完成1 期
An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- T1/2 (Terminal half-life of the analyte in plasma)
研究概览
简要总结
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table
- •For patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups:
- •Group 1 (mild dysfunction) = 50 ml/min <= Creatinine Clearance (CLcr) < 80 ml/min
- •Group 2 (moderate dysfunction) = 30 ml/min <= CLcr < 50 ml/min
- •Group 3 (severe dysfunction) = CLcr < 30 ml/min and
- •Group 4 = end-stage renal disease (ESRD) requiring dialysis
- •For patients in the hepatic group
- •Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
- •clinically diagnosed with hepatic insufficiency and Class A or B liver disease according to Child-Pugh's Classification; subjects must have a Child-Pugh score of 5-9 points
- •For patients in the normal group, i.e. normal with respect to hepatic and renal function
- •matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history
- •Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
- •No abnormalities on clinical or laboratory evaluations
- •Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception
- •Patients who are able to provide written consent and comply with study requirements
排除标准
- •Female patients who are pregnant or breast-feeding
- •Seated systolic blood pressure either < 100 mmHg or > 150 mmHg and/or heart rate either < 50 beats/min or > 90 beats/min
- •History of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject
- •Patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation
- •Patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug
- •Significant electrocardiogram (ECG) abnormalities
研究组 & 干预措施
Nevirapine
Experimental
Single dose administration
干预措施: Nevirapine (Drug)
结局指标
主要结局
T1/2 (Terminal half-life of the analyte in plasma)
时间窗: up to 7 days
MRT (Mean residence time of the analyte)
时间窗: up to 7 days
AUC (Area under the plasma concentration time curve)
时间窗: up to 7 days
Cmax (Maximum observed concentration of the analyte in plasma)
时间窗: up to 7 days
Vss/F (Volume of Distribution)
时间窗: up to 7 days
Tmax (Time of maximum concentration of the analyte in plasma)
时间窗: up to 7 days
CL/F (Apparent clearance of the analyte in plasma)
时间窗: up to 7 days
次要结局
- Number of patients with adverse events(up to 21 days)
- Number of patients with abnormal changes in laboratory parameters(Screening, Day 0, Day 7)
研究者
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