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| ID | Type | Description | Link |
|---|---|---|---|
| 272201600029C-P00026-9999-1 | 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 is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Control | Experimental | Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment |
|
| 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 - End Stage Renal Disease | Experimental | End Stage Renal Disease undergoing chronic intermittent hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-7145 | Drug | single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration, determined directly from individual concentration time data | 0-120 hours post dose |
| AUC0-inf | Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK | 0-120 hours post dose |
| Number of subjects with adverse events | 8 days post dose |
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Inclusion Criteria:
Subjects with normal renal function (Group 1) must also meet the following criteria:
• Match to one or more participants with renal impairment by gender, age, and BMI
Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
• Stable, pre-existing renal impairment
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 |
|---|---|---|---|---|---|---|
| Advanced Pharma | Miami | Florida | 33147 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| D000077722 | Ceftibuten |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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The study will enroll approximately 32 participants assigned to groups based on renal function.
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| Ceftibuten | Drug | single oral dose |
|
| Orlando |
| Florida |
| 32809 |
| United States |
| Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |