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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.105 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telotristat etiprate | Experimental | Single dose of telotristat etiprate followed by a 7-day washout. |
|
| Moxifloxacin | Active Comparator | Single dose of moxifloxacin followed by a 7-day washout. |
|
| Placebo | Placebo Comparator | Single dose of placebo with a 7-day washout to follow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | 1500 mg telotristat etiprate (six 250 mg tablets) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline QT interval corrected for heart rate | Days 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | 52 days | |
| Plasma concentration of telotristat etiprate | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman Wason, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| C000592493 | telotristat |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Matching placebo |
|
| Moxifloxacin | Drug | 400 mg moxifloxacin (one 400 mg tablet) |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |