NL-OMON48209已完成不适用
An open-label, single ascending dose study to evaluate the safety and pharmacokinetics of a tablet formulation of CG-549 in healthy subjects - CG-549 tablet pharmacokinetics study
CrystalGenomics, Inc0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Sex: male or female; females may be of childbearing potential or of
- •nonchildbearing potential (i.e., either surgically sterilized, physiologically
- •incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea
- •duration of 12 consecutive months and a serum follicle stimulating hormone
- •(FSH) >33.4 IU/L]).
- •2. Age: 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
- •4. Weight: >=50 kg at screening.
- •5. Status: healthy subjects.
排除标准
- •1. Previous participation in the current study.
- •2. Employee of PRA or the Sponsor.
- •3. History of bacterial or viral infection requiring treatment with antibiotics
- •or antivirals within 1 month prior to screening.
- •4. Presence or history of esophageal or gastroduodenal ulceration within 1
- •month prior to screening.
- •5. History of diseases or abnormalities of the liver or biliary system, other
- •than uncomplicated hepatitis A.
研究者
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