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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.108 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will receive a single oral midazolam dose on Day 1 while fasting. Days 2 to 4 will be Washout days. On Day 5, subjects will begin a 5-day regimen of telotristat etiprate. On Day 9, subjects will receive a morning dose of telotristat etiprate with a single dose of midazolam while fasting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | All subjects will receive two 250 mg telotristat etiprate tablets three times daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Midazolam plasma concentration in combination with steady state telotristat etiprate | Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | 12 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 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]). |
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| D006571 | Heterocyclic Compounds |