A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adverse Event reporting
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701
详细描述
This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in good health
- •body mass index of 20 to 29.9 kg/m2
- •female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control
排除标准
- •history or clinical manifestations of any clinically significant disorder
- •history of hypersensitivity or allergies to any drug compound
- •history of stomach or intestinal surgery or resection
- •history of alcoholism or drug addiction within 1 year
- •use of any tobacco-containing or nicotine-containing products within 6 months
- •use of any other medications
- •use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
- •pregnancy, lactation, or breastfeeding
研究组 & 干预措施
1
Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.
干预措施: TR-701 (Drug)
2
Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.
干预措施: placebo (Drug)
3
Oral doses of 600mg linezolid given twice daily for 21 days.
干预措施: linezolid (Drug)
结局指标
主要结局
Adverse Event reporting
时间窗: 21 days
次要结局
- The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700(21 days)