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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02494609

Enrollment

Registered

2015-07-10

Start date

2015-07-31

Completion date

Unknown

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGsotagliflozin

400 mg sotagliflozin

DRUGoral contraceptive

0.25 mg norgestimate/0.035 mg ethinyl estradiol

DRUGoral contraceptive + sotagliflozin

0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Number of treatment emergent adverse events	Day 1 to Day 70

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026