A Double-Blind, Placebo-Controlled, Single & Multiple Ascending Dose, Safety, Tolerability, & PK Study of an IV Form of TR-701 Free Acid & an Open-Label, Crossover Absolute BA Determination of a TR-701 FA Tablet in Normal Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety Assessments
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.
详细描述
SAD/Part A.
- All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for injection in 250 cc of saline over 180 minutes.
- Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
MAD/Part B
- Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or 200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
- Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or 300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
BA/Part C
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 post menopausal 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 manifestation of any clinically significant disorder
- •history of hypersensitivity to any drug compound
- •history of stomach or intestinal surgery or resection
- •history of infections of unexplained frequency or severity
- •history of alcoholism or drug addiction within 1 year
- •use of any tobacco- or nicotine-containing products within 6 months
- •use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or beverages
- •use of any other medications
- •pregnancy, lactation, or breastfeeding
研究组 & 干预措施
SAD/ Part A
Single IV infusions of placebo or TR-701 FA given at 50, 100, 200, and 400 mg.
干预措施: TR-701 FA for injection, 200 mg/vial (Drug)
MAD / Part B
Multiple IV infusion of placebo or TR-701 FA given daily for 7 days at 200 and 400 mg.
干预措施: TR-701 FA for injection, 200 mg/vial (Drug)
Bioavailability / Part C
TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion.
干预措施: TR-701 FA for injection, 200 mg/vial (Drug)
Bioavailability / Part C
TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion.
干预措施: TR-701 FA tablets (Drug)
Venous Tolerability/ Part D
IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days,
干预措施: TR-701 FA for injection, 200 mg/vial (Drug)
结局指标
主要结局
Safety Assessments
时间窗: 10 days
次要结局
- To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA(10 days)
- To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects(4 days)