ACTRN12621000785808招募中1 期
A Phase 1 Study to Evaluate the Effect of Itraconazole on thePharmacokinetics of GS-5718 and to Evaluate the Effect ofGS-5718 on the Pharmacokinetics of Rosuvastatin in HealthySubjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 45 Years(—)
- 性别
- All
入选标准
- •Have the ability to understand and sign a written informed consent form (ICF), which must
- •be obtained prior to initiation of study procedures
- •- Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued
- •90 days prior to the first dose of study drug.
- •- Have a calculated body mass index (BMI) of > 19.0 and < 30.0 kg/m2 at screening
排除标准
- •- Positive serum pregnancy test
- •- Breastfeeding female
- •- Male subjects who plan to donate sperm from clinic admission (eg, Day -1), throughout the
- •study period, and/or within 14 days following the last dose of study drug
- •- Have received any investigational study drug within 30 days prior to study dosing
- •- Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety, or a positive drug or alcohol test at screening or baseline
研究者
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