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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: sotagliflozin; Drug: oral contraceptive; Drug: oral contraceptive + sotagliflozin

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Lexicon Investigational Site
  • Texas
    • Dallas, Texas, United States, 75247
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Reproductive Control Agents; Contraceptive Agents, Female; Sodium-Glucose Transporter 2 Inhibitors; Contraceptive Agents; Contraceptives, Oral; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
• Other Study ID Numbers: LX4211.1-120-NRM; LX4211.120 (Other Identifier: Lexicon Pharmaceuticals, Inc.)