NCT00989872已完成1 期
A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
研究概览
简要总结
This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 adult males or females [if documentation existed that they were surgically sterilized].
- •Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor.
- •The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) <450 msec.
- •Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive.
- •Subject has read, understood, and signed the written informed consent form.
排除标准
- •History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances.
- •History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
- •Any abnormal or screening clinical lab test results...
- •Medication Related exclusions...
- •Lifestyle related...
结局指标
主要结局
The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
次要结局
未报告次要终点
研究者
研究点 (1)
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