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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supratherapeutic Dose | Experimental | 20mg/kg ACHN-490 Injection |
|
| Possible Therapeutic Dose | Experimental | 15mg/kg ACHN-490 Injection |
|
| Moxifloxacin | Active Comparator | 400mg moxifloxacin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHN-490 Injection | Drug | 20mg/kg IV 30 minute infusion given once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | In Part 1, the safety and tolerability of a single 20 mg/kg dose of ACHN-490 Injection will be assessed by measuring adverse events, blood pressure and other vital sign measurements, incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis), and physical examination, through 24 hours after study drug administration or resolution of all adverse events. | 1 day |
| Effect of ACHN-490 Injection on QTcF | The primary endpoint for Part 2 of this study is the time-matched change from baseline in QTcF within 24 hours of receiving study drug. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters | The secondary endpoints for Part 1 of this study will include relevant PK parameters such as AUC0-t, AUC0-∞, CLT, Vss, Cmax, Tmax, and t1/2 measured for 24 hours after receiving study drug. | 24 hours |
| ECG Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Achaogen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | West Bend | Wisconsin | 53095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30650259 | Derived | Gall J, Choi T, Riddle V, Van Wart S, Gibbons JA, Seroogy J. A Phase 1 Study of Intravenous Plazomicin in Healthy Adults to Assess Potential Effects on the QT/QTc Interval, Safety, and Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Nov;8(8):1032-1041. doi: 10.1002/cpdd.653. Epub 2019 Jan 16. |
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| ID | Term |
|---|---|
| C550938 | plazomicin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| ACHN-490 Injection |
| Drug |
15mg/kg IV 30 minute infusion given once |
|
| Moxifloxacin | Drug | 400mg oral pill given once |
|
| Placebo | Drug | Placebo oral pill given once |
|
Part 2 of the study will measure the effect of ACHN-490 Injection compared to placebo within 24 hours of study drug administration on heart rate, PR interval, QRS interval, QTcB, uncorrected QT interval, RR intervals, change in ST and T-wave morphology, and categorical change in QTc variables.
| 24 hours |
| PK Parameters | Part 2 of this study will measure multiple PK parameters such as AUC0-t, AUC0-∞, CLT, Vss, Cmax, Tmax, and t1/2 measured for 24 hours after receiving study drug. | 24 hours |
| Correlation between drug concentration and QTc | Part 2 of this study will measure the correlation between the QTc change from baseline and plasma concentrations of ACHN-490 Injection within 24 hours of study drug administration. | 24 hours |
| Safety and tolerability | Part 2 of this study will measure safety and tolerability of ACHN-490 Injection including adverse events, incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis) and physical examination; all for up to 44 days after receiving study drug. | Up to 44 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |