Oral Contraceptive DDI Study

Lexicon Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: sotagliflozin; Drug: oral contraceptive; Drug: oral contraceptive + sotagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02494609

LX4211.120 (Other Identifier)

LX4211.1-120-NRM

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Treatment A

Experimental group

Description:

once daily dosing for 7 days, followed by 7-day washout

Treatment:

Drug: sotagliflozin

Treatment B

Experimental group

Description:

once daily dosing for 28 days

Treatment:

Drug: oral contraceptive

Treatment C

Experimental group

Description:

once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days

Treatment:

Drug: oral contraceptive + sotagliflozin