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| ID | Type | Description | Link |
|---|---|---|---|
| 272201600029C-P00007-9999-2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule. |
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| Part 2A | Experimental | Multiple dose administration of VNRX-7145 q8h for 10 days |
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| Part 2B | Placebo Comparator | Multiple dose administration of placebo q8h for 10 days |
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| Part 3A | Experimental | Multiple dose administration of low dose VNRX-7145 + VNRX-5024 |
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| Part 3B | Experimental | Multiple dose administration of high dose VNRX-7145 + VNRX-5024 |
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| Part 3C | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-7145 | Drug | β-lactamase inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Cmax | concentration time data | 0-48 hours |
| Part 1: AUC0-inf | Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK | 0-48 hours |
| Parts 2&3: Number of subjects with adverse events | Day 15 (+2) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of subjects with adverse events | Day 14 (+2) | |
| Parts 2&3: AUC0-tau | Day 1 | |
| Parts 2&3: AUC0-tau |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Hamed, MD | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Early Development Services | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40762486 | Derived | de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5. |
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| ID | Term |
|---|---|
| D000077722 | Ceftibuten |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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Part 1: Crossover Parts 2&3: Parallel
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Part 1: Unblinded Parts 2&3: Blinded
Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024) |
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| VNRX-5024 (ceftibuten) | Drug | β-lactam antibiotic |
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| Placebo | Drug | Placebo |
|
| Day 10 |
| Parts 2&3: Cmax | Day 1 |
| Parts 2&3: Cmax | Day 10 |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |