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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.109 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | LX4211 800 mg |
|
| Treatment B | Experimental | LX4211 2000 mg |
|
| Treatment C | Active Comparator | moxifloxacin 400 mg |
|
| Treatment D | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX4211 800 mg | Drug |
| ||
| LX4211 2000 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTc intervals | Day -1, Day 1 of each period (2, 3, 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing an adverse event | up to 87 days | |
| Plasma concentrations of LX4211 | Day 1 of each Period: predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 60 hours after dosing time on Day 1 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ikenna (Ike) Ogbaa, M.D. | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
|
| moxifloxacin 400 mg | Drug |
|
| LX4211 Placebo | Drug |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |