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| ID | Type | Description | Link |
|---|---|---|---|
| 272201300019C-12-0-3 | U.S. NIH Grant/Contract | View source | |
| 17-0103 | Other Identifier | DMID |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Control | Experimental | Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment |
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| Group 2 - Mild Renal Impairment | Experimental | Mild renal impairment |
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| Group 3 - Moderate Renal Impairment | Experimental | Moderate Renal Impairment |
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| Group 4 - Severe Renal Impairment | Experimental | Severe Renal Impairment |
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| Group 5 - ESRD | Experimental | End Stage Renal Disease undergoing chronic intermittent hemodialysis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-5133 and VNRX-5022 | Drug | intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax | 72 hours |
| Area under the plasma concentration versus time curve (AUC) | To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC | 72 hours |
| Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events. | Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs) | 8 Days |
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Inclusion Criteria:
Subjects with normal renal function (Group 1) must also meet the following criteria:
Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Cliniical Research Associates | Orlando | Florida | 32809 | United States | ||
| New Orleans Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35920662 | Derived | Dowell JA, Marbury TC, Smith WB, Henkel T. Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment. Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0025322. doi: 10.1128/aac.00253-22. Epub 2022 Aug 3. |
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| ID | Term |
|---|---|
| C000707821 | taniborbactam |
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The study will enroll approximately 32 subjects assigned to treatment groups based on renal function.
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| Knoxville |
| Tennessee |
| 37920 |
| United States |