Oral Contraceptive DDI Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

sotagliflozin

Intervention Type DRUG

400 mg sotagliflozin

Treatment B

once daily dosing for 28 days

Group Type EXPERIMENTAL

oral contraceptive

Intervention Type DRUG

0.25 mg norgestimate/0.035 mg ethinyl estradiol

Treatment C

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

Group Type EXPERIMENTAL

oral contraceptive + sotagliflozin

Intervention Type DRUG

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

Interventions

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sotagliflozin

400 mg sotagliflozin

Intervention Type DRUG

oral contraceptive

0.25 mg norgestimate/0.035 mg ethinyl estradiol

Intervention Type DRUG

oral contraceptive + sotagliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes