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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
122
Oral single escalating doses of MRX-4
Multiple ascending doses of MRX-4 given twice daily for 10 days
MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Safety of single and multiple ascending doses of MRX-4
Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
Time frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 14 (Part III)
Summary of concentration time data for MRX-4 and its metabolites
Concentration time data for MRX-4 and its metabolites in blood and urine
Time frame: Pre-dose through 72 hours post dose
Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions
Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions
Time frame: Pre-dose through 72 hours post dose
Safety of MRX-4 co-administered with omeprazole
Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events
Time frame: Screening through end of study on Day 14
Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole
Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole
Time frame: Pre-dose through 72 hours post dose
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Single doses of placebo to match MRX-4
Oral placebo given twice daily for 10 days to match the oral MRX-4
Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7