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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.107 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fed condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fasted condition. |
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| Treatment B | Experimental | Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fasted condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | 2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal) |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of telotristat ethyl | Days 1, 2, 3, 6, 7, 8 | |
| Plasma concentration of metabolite LP-778902 | Days 1, 2, 3, 6, 7, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | 10 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 | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000592493 | telotristat |
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| Telotristat etiprate | Drug | 2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions) |
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