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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.104 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX4211 | Experimental | 400 mg of LX4211 administered orally |
|
| Placebo | Placebo Comparator | Nonidentical placebo administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Schedule A | Drug | Dosing 1 hour before breakfast |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary glucose excretion | 24 hours collection on Day -1 and Days 7-13 | |
| Fasting Plasma Glucose | Day -1 and Days 7-12 | |
| Postprandial Glucose | Day -1 and Days 7-12 | |
| Insulin | Day -1 and Days 7-12 | |
| Glucagon-like peptide 1 (total and active) | Day -1 and Days 7-12 | |
| Peptide YY | Day -1 and Days 7-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Day 1 to Day 14 | |
| Blood chemistry | Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ikenna Ogbaa, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23911260 | Derived | Zambrowicz B, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Boehm KA, Ruff D, Powell D, Sands A. Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects. Clin Ther. 2013 Aug;35(8):1162-1173.e8. doi: 10.1016/j.clinthera.2013.06.011. Epub 2013 Jul 31. |
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| Schedule B |
| Drug |
Dosing 0.5 hour before breakfast |
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| Schedule C | Drug | Dosing immediately before breakfast |
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| Schedule D | Drug | Dosing immediately before lunch |
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| Schedule E | Drug | Split dose, dosing 1 hour before breakfast and dinner |
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| Day -2, Day 7 and Day 13 |
| Hematology | Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts. | Day -2, Day 7 and Day 13 |