NCT00909311已完成1 期
Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
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
- Abbott
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (blood draws, pre- and post-dose)
研究概览
简要总结
The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.
详细描述
This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overall healthy subjects;
- •non-childbearing potential females included
排除标准
- •history of significant sensitivity to any drug;
- •positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
- •history of gastrointestinal issues or procedures;
- •history of seizures, diabetes or cancer (except basal cell carcinoma);
- •clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
- •use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
- •donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
- •abnormal screening laboratory results that are considered clinically significant by the investigator;
- •current enrollment in another clinical study;
- •previous enrollment in this study;
- •recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
- •pregnant or breastfeeding female;
- •requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
研究组 & 干预措施
1
Active Comparator
Non-fasting
干预措施: ABT-450 (Drug)
1
Active Comparator
Non-fasting
干预措施: ritonavir (Drug)
2
Active Comparator
Fasting
干预措施: ABT-450 (Drug)
2
Active Comparator
Fasting
干预措施: ritonavir (Drug)
结局指标
主要结局
Pharmacokinetics (blood draws, pre- and post-dose)
时间窗: 17 days
Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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