NCT01646489已完成1 期
A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
Santaris Pharma A/S1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年6月最近更新:
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
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Weight ≤ 85 kg
- •Females of non-childbearing potential (postmenopausal or surgically sterile) or males who are surgically sterile or using an acceptable form of birth control
排除标准
- •Current, clinically significant illness or medical condition
研究组 & 干预措施
Miravirsen sodium
Experimental
干预措施: Miravirsen sodium (Drug)
Telaprevir
Active Comparator
干预措施: Telaprevir (Drug)
结局指标
主要结局
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
时间窗: Up to 24 hours after dosing.
Safety and tolerability of co-administered miravirsen and telaprevir.
时间窗: 12 weeks
Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.
次要结局
- The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.(Up to 24 hours after dosing.)
研究者
研究点 (1)
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