NCT00557583已完成1 期
A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Virobay Inc.
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
研究概览
简要总结
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
详细描述
Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •males and females between 18 and 45 years of age
- •screening body mass index between 20 and 29 kg/m2
- •in good health with no clinically significant medical conditions
- •able to comprehend and willing to sign an informed consent
排除标准
- •history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
- •anemia or blood donation within 8 weeks of check-in
- •plasma donation within 4 weeks of check-in
- •history of alcoholism or drug addiction within 1 year prior to check-in
- •use of drugs of abuse
- •no tobacco-containing products within 6 months of study
- •participation of any clinical trial within 30 days
- •history or presence of abnormal ECG
- •no prescription or over-the-counter medications within 14 days of study and during the study
- •history of Gilbert's syndrome
结局指标
主要结局
To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
时间窗: 7 days
次要结局
- To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.(7 days)
研究者
研究点 (2)
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