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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.106 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will receive a single oral dose of fexofenadine on Day 1 while fasting. Days 2 to 5 will be Washout days. On Day 6, subjects will begin a 5 day telotristat etiprate regimen. On Day 10 subjects will be given the morning telotristat etiprate dose concomitantly with a single dose of fexofenadine while fasting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine | Drug | All subjects will receive 180 mg fexofenadine |
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| Measure | Description | Time Frame |
|---|---|---|
| Fexofenadine plasma concentration in combination with steady state telotristat etiprate | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | 14 days |
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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 | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
| C000592493 | telotristat |
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| Telotristat etiprate |
| Drug |
All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily |
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