A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Safety of single and multiple ascending doses of MRX-4
研究概览
简要总结
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
排除标准
- •Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
研究组 & 干预措施
Single intravenous doses of MRX-4
Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg
干预措施: Single intravenous doses of MRX-4 (Drug)
Single intravenous doses of placebo
Single intravenous doses of placebo to match MRX-4
干预措施: Single intravenous doses of placebo (Drug)
Multiple intravenous doses of MRX-4
Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg
干预措施: Multiple intravenous doses of MRX-4 (Drug)
Multiple intravenous doses of placebo
Twice daily intravenous doses of placebo to match MRX-4 for 10 days
干预措施: Multiple intravenous doses of placebo (Drug)
Single dose of intravenous and oral MRX-4
Crossover of single dose of intravenous and oral MRX-4
干预措施: Single dose of intravenous and oral MRX-4 (Drug)
结局指标
主要结局
Safety of single and multiple ascending doses of MRX-4
时间窗: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events
次要结局
- Plasma concentration time data for MRX-4 and its metabolites(Pre-dose through 72 hours post dose)
- Bioavailability of MRX-I and other MRX-4 metabolites(Pre-dose through 72 hours post dose)
- Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites(Pre-dose through 72 hours post dose)
- Elimination of MRX-4 and its metabolites in the urine following single dose adminstration(Pre-dose through 72 hours post dose)