A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cmax of mifepristone at Day 42 compared to Day 28
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 daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Male
- 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
排除标准
- •Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
- •Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- •In the 1 year before study drug administration, have a history of drug or alcohol abuse
- •In the 6 calendar months before study drug administration, on average
- •Have smoked more than 5 cigarettes/day
- •Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
- •In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
- •In the 30 days before 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
Arm 1
Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
干预措施: Mifepristone 300 MG (Drug)
Arm 1
Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
干预措施: Itraconazole 100 MG (Drug)
结局指标
主要结局
Cmax of mifepristone at Day 42 compared to Day 28
时间窗: Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
AUC0-24 of mifepristone at Day 42 compared to Day 28
时间窗: Day 42 compared to Day 28
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
次要结局
- Cmax of mifepristone at Day 42 compared to Day 14(Day 42 compared to Day 14)
- Ctrough of mifepristone(Days 1 through 28)
- AUC0-24 of mifepristone compared to Day 14(Day 42 compared to Day 14)
- T1/2 of mifepristone(Days 14 and 28)