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This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin |
|
| Sequence 2 | Experimental | In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plazomicin | Drug | single intravenous dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of metformin in plasma | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 15 days | |
| Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure) | 8 days | |
| Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyeilla Dhuria | Achaogen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30605260 | Derived | Choi T, Komirenko AS, Riddle V, Kim A, Dhuria SV. No Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Aug;8(6):818-826. doi: 10.1002/cpdd.648. Epub 2019 Jan 3. |
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| ID | Term |
|---|---|
| C550938 | plazomicin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| metformin |
| Drug |
single oral dose |
|
| 9 days |
| Pharmacokinetics of metformin in urine | 9 days |
| Pharmacokinetics of plazomicin in plasma | 9 days |