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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.120 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | once daily dosing for 7 days, followed by 7-day washout |
|
| Treatment B | Experimental | once daily dosing for 28 days |
|
| Treatment C | Experimental | once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sotagliflozin | Drug | 400 mg sotagliflozin |
| |
| oral contraceptive |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters | Day 6 to Day 8, Day 55 to Day 57, Day 62 to Day 64 | |
| Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters | Day 55 to Day 57, Day 62 to Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | Day 1 to Day 70 |
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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 | ||
| Lexicon Investigational Site |
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| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Drug |
0.25 mg norgestimate/0.035 mg ethinyl estradiol |
|
| oral contraceptive + sotagliflozin | Drug | 0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin |
|
| Dallas |
| Texas |
| 75247 |
| United States |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |