Oral Contraceptive DDI Study

A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and Ortho-Cyclen®, an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women

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.

Inclusion Criteria:

• Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
• Have not received any oral contraceptives during the Screening period or for at least 15 days prior to the first dose of Period 1

Exclusion Criteria:

• History of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
• Prior exposure to sotagliflozin (LX4211)
• History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
• Concurrent conditions that could interfere with safety and/or tolerability measurements
• Women who are breastfeeding or are planning to become pregnant during the study
• Positive serum pregnancy test
• Have taken injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1 or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1