A Phase 1 interventional study of Single intravenous doses of MRX-4 and Single intravenous doses of placebo in Safety, sponsored by MicuRx. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by MicuRx · Phase 1, Interventional, and Treatment
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.
MicuRx is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg
Drug: Single intravenous doses of MRX-4
Single intravenous doses of placebo to match MRX-4
Drug: Single intravenous doses of placebo
Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg
Drug: Multiple intravenous doses of MRX-4
Twice daily intravenous doses of placebo to match MRX-4 for 10 days
Drug: Multiple intravenous doses of placebo
Crossover of single dose of intravenous and oral MRX-4
Drug: Single dose of intravenous and oral MRX-4
Intravenous single escalating doses of MRX-4
Intravenous single doses of placebo to match MRX-4
Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4
Safety of single and multiple ascending doses of MRX-4
Summary statistics 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 visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
Plasma concentration time data for MRX-4 and its metabolites
Individual and mean plasma concentration time data for MRX-4 and its metabolites
Time frame: Pre-dose through 72 hours post dose
Bioavailability of MRX-I and other MRX-4 metabolites
Levels of MRX-4 and its metabolites in blood
Time frame: Pre-dose through 72 hours post dose
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites
Levels of MRX-4 and its metabolites in blood
Time frame: Pre-dose through 72 hours post dose
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration
Levels of MRX-4 and its metabolites in urine
Time frame: Pre-dose through 72 hours post dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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