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drugset / Trial / NCT03033342

Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4

NCT03033342 ↗

Phase 1 Completed 122 enrolled MicuRx Worldwide Clinical Trials · collab
RandomizedParallel-groupQuadruple-blindOther

Summary

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

Timeline

Start
2016-08-02
Primary completion
2017-02-01
Completion
2017-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject MRX-4 Small molecule 250 mg Oral
Subject MRX-4 Small molecule 500 mg Oral
Subject MRX-4 Small molecule 750 mg Oral
Subject MRX-4 Small molecule 1000 mg Oral
Subject MRX-4 Small molecule 1500 mg Oral
Subject MRX-4 Small molecule 3000 mg Oral
Background Omeprazole Other / unclassified — —

Indications

No indication recorded.