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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral single doses of MRX-4 | Experimental | Single escalating oral doses of MRX-4 from 250 mg to 3000 mg |
|
| Oral multiple doses of MRX-4 | Experimental | Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg |
|
| MRX-4 co-administered with omeprazole | Experimental | Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4. |
|
| Oral single doses of placebo | Placebo Comparator | Single oral doses of placebo to match MRX-4 |
|
| Oral multiple doses of placebo | Placebo Comparator | Multiple oral doses of placebo given twice daily for 10 days to match MRX-4 |
|
| Placebo co-administered with omeprazole |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral single doses of MRX-4 | Drug | Oral single escalating doses of MRX-4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Pre-dose through 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-dose through 72 hours post dose |
| Safety of MRX-4 co-administered with omeprazole |
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Inclusion Criteria:
Exclusion Criteria:
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The study results will be published in the future
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Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole |
|
| Oral multiple doses of MRX-4 |
| Drug |
Multiple ascending doses of MRX-4 given twice daily for 10 days |
|
| MRX-4 co-administered with omeprazole | Drug | MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7 |
|
| Oral single doses of placebo | Drug | Single doses of placebo to match MRX-4 |
|
| Oral multiple doses of placebo | Drug | Oral placebo given twice daily for 10 days to match the oral MRX-4 |
|
| Placebo co-administered with omeprazole | Drug | Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7 |
|
Summary 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 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 | Pre-dose through 72 hours post dose |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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