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Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. |
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| Treatment sequence 2 | Experimental | Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL7080 | Drug | 7 doses of POL7080 alone over 2.5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax) | Up to 4 days for each period | |
| Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC) | Up to 4 days for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse Events | up to 19 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | Germany |
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| ID | Term |
|---|---|
| C000629572 | murepavadin |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Amikacin | Drug | 3 doses of Amikacin alone over 2.5 days |
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| POL7080 + Amikacin | Drug | 7 doses of POL7080 and 3 doses of Amikacin over 2.5 days |
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