Oral Contraceptive DDI Study

Phase 1

• Conditions: Healthy
• Interventions: Drug: oral contraceptive; Drug: sotagliflozin; Drug: oral contraceptive + sotagliflozin

• Registration Number: NCT02494609
• Lead Sponsor: Lexicon Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Primary Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment B	oral contraceptive	once daily dosing for 28 days
Treatment A	sotagliflozin	once daily dosing for 7 days, followed by 7-day washout
Treatment C	oral contraceptive + sotagliflozin	once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of treatment emergent adverse events	Day 1 to Day 70

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Dallas, Texas, United States