A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Cmax of Proellex
研究概览
简要总结
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
详细描述
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
- •Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
- •Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
- •Must have a negative urine pregnancy test at screening
- •Able to swallow gelatin capsules
- •Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
- •Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
- •Other inclusion criteria may apply
排除标准
- •Symptomatic uterine fibroids or endometriosis
- •Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
- •Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
- •Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
- •Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
- •Other exclusion criteria may apply
研究组 & 干预措施
25 mg AMCC fed
25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fed State
干预措施: Proellex (Drug)
25 mg AMCC fasting
25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fasting State
干预措施: Proellex (Drug)
50 mg AMCC fed
2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose
Fed State
干预措施: Proellex (Drug)
50 mg AMCC fasting
2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose
Fasting State
干预措施: Proellex (Drug)
50 mg SMCC fasting
2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose
Fasting State
干预措施: Proellex (Drug)
结局指标
主要结局
Cmax of Proellex
时间窗: Up to 72 hours post-dose
Maximum observed concentration of Proellex
Terminal Elimination Half-life (T1/2) of Proellex
时间窗: Up to 72 hours post dose
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
AUC0-last of Proellex
时间窗: Up to 72 hours post dose
Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.
Tmax of Proellex
时间窗: Up to 72 hours post dose
Time to maximum plasma occurrence of Cmax
AUC0-infinity of Proellex
时间窗: Up to 72 hours post dose
Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration
次要结局
未报告次要终点