Oral Contraceptive DDI Study
This trial is active, not recruiting.
|Treatments||sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin|
|Start date||July 2015|
|End date||November 2015|
|Trial size||30 participants|
|Trial identifier||NCT02494609, LX4211.1-120-NRM, LX4211.120|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
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
Number of treatment emergent adverse events
time frame: Day 1 to Day 70
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
|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|
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