Oral Contraceptive DDI Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: sotagliflozin
* Drug: oral contraceptive
* Drug: oral contraceptive + sotagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>once daily dosing for 7 days, followed by 7-day washout | Drug: sotagliflozin<br>* 400 mg sotagliflozin<br>|
| Experimental: Treatment B<br>once daily dosing for 28 days | Drug: oral contraceptive<br>* 0.25 mg norgestimate/0.035 mg ethinyl estradiol<br>|
| Experimental: Treatment C<br>once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days | Drug: oral contraceptive + sotagliflozin<br>* 0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events |  | Day 1 to Day 70 |