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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.109 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Single oral dose of 500 mg telotristat etiprate on Day 1 |
|
| Period 2 | Other | Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | 500 mg telotristat etiprate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of telotristat ethyl | Days 1, 2, 3, 6, 7, 8 | |
| Plasma concentrations of metabolite LP-778902 | Days 1, 2, 3, 6, 7, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Up to 39 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 | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C000592493 | telotristat |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Octreotide acetate |
| Drug |
200 µg octreotide acetate three times daily |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |