NCT00931281已完成1 期
A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses 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
- 38
- 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 pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.
详细描述
This is a multiple ascending dose, non-fasting, open label, randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 within the 6-month period prior to study drug administration
- •donation or loss of 550mL 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
ABT-450/ritonavir
干预措施: ABT-450 (Drug)
1
Active Comparator
ABT-450/ritonavir
干预措施: ritonavir (Drug)
2
Placebo Comparator
Placebo for ABT-450/placebo for ritonavir
干预措施: Placebo for ABT-450 (Drug)
2
Placebo Comparator
Placebo for ABT-450/placebo for ritonavir
干预措施: Placebo for 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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