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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.114 | 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 administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 0.5 mg single-dose oral digoxin administration |
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| Treatment B | Experimental | 400 mg oral LX4211 qd administration |
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| Treatment C | Experimental | 0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A digoxin | Drug | 0.5 mg digoxin administered on Day 1 and Day 20 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Day 1-Day 7, Day 20-26 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Day 1-Day 26 |
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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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| Treatment B LX4211 |
| Drug |
400 mg LX4211 administered daily on Day 14 through Day 25 |
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| Treatment C Digoxin + 400 mg LX4211 administered concomitantly | Drug | 0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20 |
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