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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.115 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 10 mg oral rosuvastatin administration |
|
| Treatment B | Experimental | 400 mg oral LX4211 qd administration |
|
| Treatment C | Experimental | 10 mg oral rosuvastatin administration + 400 mg oral LX4211 qd administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A (rosuvastatin) | Drug | 10 mg rosuvastatin administered on Day 1 and Day 13 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Day 1-Day 5, Day 13-Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| # of Adverse Events | Day 1-Day 17 |
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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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Treatment B (LX4211) |
| Drug |
400 mg LX4211 administered on Day 7 through Day 13 |
|
| Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly) | Drug | 10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13 |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |