NCT03258372已完成1 期
A Phase 1, Open-Label, Fixed-Sequence, Crossover Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inducer of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3
研究概览
简要总结
This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the exposure of mifepristone at 2 dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be healthy
- •Have a BMI of 18 to 32 kg/m2, inclusive, and body weight more than 50 kg (110 pounds)
- •Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
- •Have suitable veins for multiple venipuncture/cannulation
- •Female subjects of childbearing potential must use highly effective contraception with low user-dependency. The only acceptable method is an intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of study drug and undertakes not to have it removed for 1 month after the last dose of study drug. Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.
排除标准
- •Have multiple drug allergies, or be allergic to any of the components of mifepristone or rifampin
- •Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- •Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma
- •Breastfeeding
- •In the 1 year before first study drug administration, have a history of drug or alcohol abuse
- •In the 6 calendar months before first study drug administration, on average
- •Have smoked more than 5 cigarettes/day
- •Have consumed more than 21 units of alcohol/week for male subjects or 14 units for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
- •In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL
- •In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
研究组 & 干预措施
Cohort 1
Experimental
Mifepristone 300 MG, 1 tablet
干预措施: Mifepristone (Drug)
Cohort 2
Experimental
Mifepristone 1500 MG, 5 tablets
干预措施: Mifepristone (Drug)
结局指标
主要结局
Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3
时间窗: 18 days
Maximum (peak) plasma drug concentration (Cmax)
AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3
时间窗: 18 days
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3
时间窗: 18 days
Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)
次要结局
- Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3(18 days)
- AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3(18 days)
- AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3(18 days)
研究者
研究点 (1)
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