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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.9% saline infusion | Placebo Comparator | Saline 0.9% infusion |
|
| AAI101 i.v. | Experimental | 600 mg, 1g, 2g, 4g, 1g q6h, 2g q6h. Drug-Drug Interaction: Sequence 1 = piperacillin 4 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v. - cefepime 2 g i.v. - AAI101 2 g + cefepime 2 g i.v. Sequence 2 = cefepime 2 g i.v. - piperacillin 4 g i.v. - AAI101 2 g + cefepime 2 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v. |
|
| Piperacillin i.v. | Experimental | Piperacillin 3 g |
|
| Cefepime i.v. | Experimental | Cefepime 1 g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAI101 i.v. | Drug | 600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile - Number of Subjects With at Least one Adverse Event | Safety will be evaluated from reported signs and symptoms and clinical laboratory tests | Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AAI101 maximum plasma concentration (Cmax) | Cmax will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin | Up to 24 hours post-dose |
| AAI101 Clast |
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Inclusion Criteria:
Main Exclusion Criteria:
Healthy male subjects
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| ID | Term |
|---|---|
| C000656730 | enmetazobactam |
| D012965 | Sodium Chloride |
| D008997 | Monobactams |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline 0.9% infusion | Drug | Vehicle infusion |
|
|
| Piperacillin i.v. | Drug | piperacillin 3 g i.v. |
|
|
| Cefepime i.v. | Drug | cefepime 1 g i.v. |
|
|
Clast will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin
| Up to 24 hours post-dose |
| AAI101 AUC(0-t) - AUC(0-8) | AAI101 Urea Under the Curve will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin | Up to 24 hours post-dose |
| AAI101 half life (t1/2) | AAI101 t1/2 plasma pharmacokinetic parameter will be compared for AAI101 alone or in the presence of cefepime or piperacillin | Up to 24 hours post-dose |
| D017670 |
| Sodium Compounds |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |