Overview

This trial is active, not recruiting.

Condition healthy
Treatments sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin
Phase phase 1
Sponsor Lexicon Pharmaceuticals
Start date July 2015
End date November 2015
Trial size 30 participants
Trial identifier NCT02494609, LX4211.1-120-NRM, LX4211.120

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
once daily dosing for 7 days, followed by 7-day washout
sotagliflozin
400 mg sotagliflozin
(Experimental)
once daily dosing for 28 days
oral contraceptive
0.25 mg norgestimate/0.035 mg ethinyl estradiol
(Experimental)
once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days
oral contraceptive + sotagliflozin
0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Primary Outcomes

Measure
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
time frame: 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
time frame: Day 55 to Day 57, Day 62 to Day 64

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Lexicon Pharmaceuticals.