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| Name | Class |
|---|---|
| Eric Solutions LLC | UNKNOWN |
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This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zidebactam Cefepime | Experimental | Zidebactam Cefepime 3gm Vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidebactam-Cefepime | Drug | (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess Plasma Pharmacokinetics Parameters | Maximum concentration (Cmax) | Day 1, 4, 7 |
| To assess Plasma Pharmacokinetics Parameters | Area under the concentration time curve up to infinity (AUC0-inf) for each analyte | Day 1, 4, 7 |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Plasma Pharmacokinetics Parameters Area Under Concentration | Area Under Concentration Time curve up to last measurable time point (AUClast) | Day 1, 4, 7 |
| To Assess Plasma Pharmacokinetics Parameters Time to reach maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Protein Binding | Protein binding for cefepime and zidebactam when ZID-FEP is administered alone | Day 1, 4, 7 |
| Measurement of Plasma PK Parameters | Serial blood samples will be collected from all subjects for determination of drug concentration-time profiles and PK parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | United States |
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| Metronidazole | Drug | (2) metronidazole 0.5 g IV alone administered over 1 h |
|
| FEP-ZID | Drug | (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period. |
|
Time to reach maximum concentration (Tmax)
| Day 1, 4, 7 |
| To Assess Plasma Pharmacokinetics Parameters Terminal elimination half-life | Terminal elimination half-life (T½) | Day 1, 4, 7 |
| To Assess Plasma Pharmacokinetics Parameters Plasma Clearance | Plasma Clearance (CL) | Day 1, 4, 7 |
| To Assess Plasma Pharmacokinetics Parameters Volume of Distribution | Volume of Distribution (Vz) | Day 1, 4, 7 |
| Day 1, 4, 7 |
| ID | Term |
|---|---|
| C000624485 | cefepime-zidebactam |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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