An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of TR-701 600mg given as a single oral dose.
研究概览
简要总结
This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
详细描述
Subjects will receive the following treatments in a crossover design:
Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.
Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.
Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •BMI of 20 to 29.9 kg/m2
- •Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control
排除标准
- •history or clinical manifestations of any clinically significant medical 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
- •pregnancy, lactation, or breastfeeding
- •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
研究组 & 干预措施
after fast
Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
干预措施: TR-701 600mg (Drug)
After high fat food
Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.
干预措施: TR-701 600mg (Drug)
结局指标
主要结局
To determine the safety and tolerability of TR-701 600mg given as a single oral dose.
时间窗: 4 days
次要结局
- To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state(4 days)