NL-OMON49788已完成不适用
A Phase 1 Study to Evaluate the Potential Drug-Drug Interaction between GS-4224 and Probe Inhibitors, Inducers and Substrates in Healthy Subjects - GS-US-439-5302 DDI study in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Have the ability to understand and sign a written informed consent form
- •(ICF), which must be obtained prior to initiation of study procedures
- •2) Be aged 18 through 45 years of age, inclusive at screening
- •3) Be a nonsmoker. The use of nicotine or nicotine-containing products must be
- •discontinued 90 days prior to the first dose of study drug.
- •4) Have a calculated body mass index (BMI) of >= 19.0 and <= 30.0 kg/m2 at
- •Further criteria apply.
排除标准
- •1) Pregnant or lactating female
- •2) Received any study drug within 60 days prior to study dosing
- •3) 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
- •4) A positive test result for human immunodeficiency virus type 1 (HIV-1)
- •antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •antibody at screening
- •a) Subjects who are HCV Ab positive, but have a documented negative HCV RNA,
- •are eligible
- •5) Have a positive test result for autoantibodies (ANA >1:80 and/or SMA >1:80
- •and/or AMA>1:40 and/or anti-TPO >1:40; or lab equivalent for positivity)
- •Further criteria apply.
研究者
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