Oral Contraceptive DDI Study

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