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| Name | Class |
|---|---|
| Cardiokine Biopharma, LLC | INDUSTRY |
| Biogen | INDUSTRY |
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This is a Phase 1, double-blind, randomized, repeat-dose, single -dite, 4-arm parallel group study to define the ECG effect of lixivaptan using a therapeutic and supratherapeutic dose compared to placebo and moxifloxacin (a positive control in healthy adult men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo by mouth |
|
| B | Experimental | lixivaptan |
|
| C | Active Comparator | moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | capsules |
| |
| lixivaptan |
| Measure | Description | Time Frame |
|---|---|---|
| Timed-matched, placebo-corrected, changed from Baseline in QTc | 7days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C409452 | lixivaptan |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
capsules |
|
| moxifloxacin | Drug | tablets |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |