A Single-Dose, Open-Label, Pharmacokinetic Study Of Ulipristal Acetate In Healthy Subjects With Normal Renal Function And Patients With Moderately Or Severly Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Maximum plasma drug concentration (Cmax) of ulipristal acetate
研究概览
简要总结
This study is designed to observe the effect of renal function on the pharmacokinetic, safety, and tolerability profiles of Ulipristal acetate following administration of a single oral dose of a 10 mg Ulipristal acetate tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Known hypersensitivity to Ulipristal Acetate (UPA) or other selective progesterone receptor modulators
- •For Patients with Renal Impairment, clinically significant disease state, in the opinion of the examining physician, in any body system (other than renal function impairment)
- •For Patients with Normal Renal Function, clinically significant disease state, in the opinion of the examining physician, in any body system
- •Positive test results for anti-human immunodeficiency virus type 1, hepatitis B surface antigen, or anti-hepatitis C virus at screening
- •Abnormal and clinically significant results on physical examination, medical history, serum chemistry, hematology, or urinalysis
- •History of alcohol or other substance abuse within the previous 5 years
- •Positive test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, or phencyclidine at screening or Day -
- •Patients with Renal Impairment many be enrolled if the positive test result is due to prescription drug use and approved by the Principal Investigator and Sponsor Study Physician, on a case-by-case basis
- •Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days of IP administration
- •Participation in a blood or plasma donation program within 60 or 30 days, respectively, of Investigational Product (IP) administration
- •Previously participated in an investigational study of Ulipristal Acetate
- •Breastfeeding
研究组 & 干预措施
Normal Renal Function
Ulipristal acetate, 10 mg, oral administration
干预措施: Ulipristal acetate (Drug)
Moderate Renal Impairment
Ulipristal acetate, 10 mg, oral administration
干预措施: Ulipristal acetate (Drug)
Severe Renal Impairment
Ulipristal acetate, 10 mg, oral administration
干预措施: Ulipristal acetate (Drug)
结局指标
主要结局
Maximum plasma drug concentration (Cmax) of ulipristal acetate
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to time t (AUC 0-t)
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of ulipristal acetate
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Terminal elimination half-life (T½) of ulipristal acetate
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Apparent total body clearance of ulipristal acetate from plasma after extravascular administration (CL/F) of ulipristal acetate
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of ulipristal acetate
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to infinity (AUC 0-∞)
时间窗: Day 1 (0 hour) to Day 8 (168 hours)
次要结局
- Cumulative amount of ulipristal acetate excreted into urine from time zero to time t (Ae0-t)(Day 1 (0 hour) to Day 8 (168 hours))
- Area under the plasma concentration versus time curve of PGL4002 (ulipristal acetate active metabolite) from time 0 to time t (AUC 0-t)(Day 1 (0 hour) to Day 8 (168 hours))
- Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite)(Day 1 (0 hour) to Day 8 (168 hours))
- Terminal elimination half-life (T½) of PGL4002 (ulipristal acetate active metabolite)(Day 1 (0 hour) to Day 8 (168 hours))
- Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite)(Day 1 (0 hour) to Day 8 (168 hours))
- Renal clearance of ulipristal acetate from plasma (CLR)(Day 1 (0 hour) to Day 8 (168 hours))
- Renal clearance of PGL4002 from plasma (CLR)(Day 1 (0 hour) to Day 8 (168 hours))
- Area under the plasma concentration versus time curve of PGL4002 (ulipristal acetate active metabolite) from time 0 to infinity (AUC 0-∞)(Day 1 (0 hour) to Day 8 (168 hours))
- Percent of dose excreted as unchanged ulipristal acetate in urine (%Dose)(Day 1 (0 hour) to Day 8 (168 hours))
- Cumulative amount of PGL4002 excreted into urine from time zero to time t (Ae0-t)(Day 1 (0 hour) to Day 8 (168 hours))