NCT00787618终止1 期
A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Cmax of Proellex
研究概览
简要总结
PK and safety profile of Proellex® in females with various stages of impaired renal function
详细描述
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- •Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
- •Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
- •Subject with renal impairment must have evidence of stable disease
- •If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
- •Negative urine pregnancy test at screening visit
- •Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
- •Healthy subject must have no significant abnormal findings at the screening physical examination
- •Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
- •Additional inclusion criteria may apply
排除标准
- •Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
- •Subject with clinically significant abnormal liver function
- •Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
- •An acute illness within five (5) days of study medication administration
- •Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
- •Additional exclusion criteria may apply
研究组 & 干预措施
50 mg Proellex Mild impairment
Active Comparator
50 mg Proellex single dose Female subjects with mild renal impairment function.
干预措施: 50 mg Proellex (Drug)
50 mg Proellex Moderate
Active Comparator
50 mg Proellex, Female subjects with moderate renal impairment function.
干预措施: 50 mg Proellex (Drug)
50 mg Proellex, Normal
Active Comparator
50 mg Proellex, Female subjects with normal renal function.
干预措施: 50 mg Proellex (Drug)
结局指标
主要结局
Cmax of Proellex
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (4)
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