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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intravenous doses of MRX-4 | Experimental | Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg |
|
| Single intravenous doses of placebo | Placebo Comparator | Single intravenous doses of placebo to match MRX-4 |
|
| Multiple intravenous doses of MRX-4 | Active Comparator | Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg |
|
| Multiple intravenous doses of placebo | Placebo Comparator | Twice daily intravenous doses of placebo to match MRX-4 for 10 days |
|
| Single dose of intravenous and oral MRX-4 | Active Comparator | Crossover of single dose of intravenous and oral MRX-4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single intravenous doses of MRX-4 | Drug | Intravenous single escalating doses of MRX-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration time data for MRX-4 and its metabolites | Individual and mean 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Single intravenous doses of placebo | Drug | Intravenous single doses of placebo to match MRX-4 |
|
| Multiple intravenous doses of MRX-4 | Drug | Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days |
|
| Multiple intravenous doses of placebo | Drug | Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days |
|
| Single dose of intravenous and oral MRX-4 | Drug | Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4 |
|
Levels of MRX-4 and its metabolites in blood
| 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 | 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 | Pre-dose through 72 hours post dose |