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| ID | Type | Description | Link |
|---|---|---|---|
| 272201300019C-3-0-1 | U.S. NIH Grant/Contract | View source | |
| 17-0068 | Other Identifier | DMID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A | Experimental | In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule.. |
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| Part 1B | Experimental | In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. |
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| Part 2 - 2A | Experimental | Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022 |
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| Part 2 - 2B | Experimental | Multiple dose administration of High Dose VNRX-5133 + VNRX-5022 |
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| Part 2 - 2C | Placebo Comparator | Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-5133 | Drug | β-lactamase inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) | Cmax | 0-48 hours |
| Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) | AUCinf | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) | Cmax | 0-48 hours |
| Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) |
| Measure | Description | Time Frame |
|---|---|---|
| Bactericidal titers (Part 2) | To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022 | 10 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRAHS | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000707821 | taniborbactam |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Part 1: Cross-over Part 2: Parallel
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| VNRX-5022 | Drug | Approved β-lactam antibiotic |
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| Metronidazole | Drug | Approved antibiotic and antiprotozoal medication |
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| Placebo | Drug | Placebo (matching VNRX-5133 + VNRX-5022) |
|
AUCinf
| 0-48 hours |
| Number of Subjects with Treatment Emergent Adverse Events | TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis. | First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days |
| Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration | Trough concentration levels from Day 1 - Day 10 | Part 2: 10 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |