Randomized, Double-Blind, Placebo-Controlled Three-Part Phase 1 Study of Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX-4 Administered Orally to Healthy Volunteers in Single and Multiple Ascending Dose Cohorts to Evaluate Drug Interactions With Omeprazole
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 主要终点
- Safety of single and multiple ascending doses of MRX-4
研究概览
简要总结
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in:
single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.
other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
Oral single doses of MRX-4
Single escalating oral doses of MRX-4 from 250 mg to 3000 mg
干预措施: Oral single doses of MRX-4 (Drug)
Oral multiple doses of MRX-4
Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg
干预措施: Oral multiple doses of MRX-4 (Drug)
MRX-4 co-administered with omeprazole
Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.
干预措施: MRX-4 co-administered with omeprazole (Drug)
Oral single doses of placebo
Single oral doses of placebo to match MRX-4
干预措施: Oral single doses of placebo (Drug)
Oral multiple doses of placebo
Multiple oral doses of placebo given twice daily for 10 days to match MRX-4
干预措施: Oral multiple doses of placebo (Drug)
Placebo co-administered with omeprazole
Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole
干预措施: Placebo co-administered with omeprazole (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 14 (Part III)
Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
Summary of concentration time data for MRX-4 and its metabolites
时间窗: Pre-dose through 72 hours post dose
Concentration time data for MRX-4 and its metabolites in blood and urine
次要结局
- Safety of MRX-4 co-administered with omeprazole(Screening through end of study on Day 14)
- Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole(Pre-dose through 72 hours post dose)
- Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions(Pre-dose through 72 hours post dose)