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
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment A
once daily dosing for 7 days, followed by 7-day washout
干预措施: sotagliflozin (Drug)
Treatment B
once daily dosing for 28 days
干预措施: oral contraceptive (Drug)
Treatment C
once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days
干预措施: oral contraceptive + sotagliflozin (Drug)
结局指标
主要结局
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
时间窗: 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
时间窗: Day 55 to Day 57, Day 62 to Day 64
次要结局
- Number of treatment emergent adverse events(Day 1 to Day 70)