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The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).
This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oritavancin | Experimental | Single-dose intravenous (IV) oritavancin diphosphate |
|
| Placebo | Placebo Comparator | Single-dose IV placebo |
|
| Moxifloxacin | Active Comparator | Moxifloxacin tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | Drug | Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-adjusted change from Baseline in QTcF | Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo. | predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses. | Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses. | predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time |
| Placebo adjusted change from Baseline in the appearance or worsening of ST, T and U-wave morphology. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Sanabria, MD | Spaulding Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical | West Bend | Wisconsin | 53095 | United States |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Placebo | Drug | Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours. |
|
| Moxifloxacin | Drug | Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion. |
|
|
Placebo adjusted change from baseline in the appearance or worsening of ST, T and U-wave morphology. |
| predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time |
| Effects on the QTc interval related to plasma concentration levels of oritavancin | Compare the effects on the QTc interval to the plasma levels of oritavancin using concentration-effect modeling | predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time |
| Evaluate the number of volunteers with adverse events or abnormalities in lab/urine results and safety ECGs as measures of safety and tolerability | Compare safety and tolerability in healthy volunteers after a single IV dose of 1600 mg oritavancin | Day 0 through Day 7 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |