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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-115 | Other Identifier | TriusRX unique ID |
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The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin 400 mg | Active Comparator |
| |
| TR-701 FA 1200 mg | Experimental |
| |
| TR-701 FA 200 mg plus Placebo | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 FA 1200 mg | Drug | 6 tablet of T-701 FA |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| QTcF Change from Baseline | Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF). | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe G Prokocimer, MD | Trius Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Investigator | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27342387 | Background | Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2. |
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| ID | Term |
|---|---|
| C546016 | tedizolid |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin 400 mg | Drug | 1 tablet 400 mg Moxifloxacin |
|
| TR-701 FA 200 mg plus Placebo | Drug | 1 tablet of TR-701 FA with 5 tablet placebo |
|
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| Placebo | Drug | 6 placebo tablets |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |