NCT03092999已完成1 期
Investigation of Pharmacokinetics, Safety, and Tolerability of Vilaprisan (BAY1002670) in Subjects With Hepatic Impairment (Classified as Child-Pugh A or B) Compared to Sex, Age, and Weight-matched Healthy Subjects Following a Single Oral Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
研究概览
简要总结
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all subjects:
- •The informed consent must be signed before any study specific tests or procedures are done
- •White/Caucasian men and women aged between 18 to 79 years (inclusive )
- •Body mass index (BMI): 18 to 34 kg/m2 (both inclusive)
- •Ability to understand and follow study-related instructions
- •Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and three months after administration of study drug. Subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active.
- •This is not required if safe contraception is achieved by a permanent method, such as hysterectomy, bilateral fallopian tube ligation or vasectomy.
- •For subjects with hepatic impairment:
- •Subjects with documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, or ultrasound
- •Subjects with hepatic impairment (Child-Pugh A or B)
- •Subjects with stable liver disease, i.e. same Child-Pugh class in the last 2 months
排除标准
- •Any relevant disease within 4 weeks prior to study drug administration requiring medical treatment
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Use containing sex hormones within 4 weeks to six months before first study drug administration
- •Use of CYP3A4 and P-glycoprotein inhibitors or inducers
- •Use of drugs which may affect absorption
- •Major change of medication <2 weeks prior study drug administration
- •Deviations from normal range in physical examination, gynecological examination, clinical chemistry, hematology, or urinalysis considered to be relevant by the investigator
- •Any criteria which, in the opinion of the investigator, make study participation unadvisable for scientific, compliance, safety, or medical reasons
研究组 & 干预措施
Healthy subjects
Experimental
healthy subjects
干预措施: Vilaprisan (BAY1002670) (Drug)
Subjects with mild hepatic impairment
Experimental
hepatically impaired patients (classified as Child Pugh A)
干预措施: Vilaprisan (BAY1002670) (Drug)
Subjects with moderate hepatic impairment
Experimental
hepatically impaired patients (classified as Child Pugh B)
干预措施: Vilaprisan (BAY1002670) (Drug)
结局指标
主要结局
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
时间窗: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Exposure of Vilaprisan in plasma following a single dose administration
Maximum observed (unbound) drug concentration (Cmax,u)
时间窗: At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 days
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
次要结局
- Changes in Vital Signs(Up to 20 days)
- Changes in urine laboratory parameters(Up to 20 days)
- Frequency of Treatment Emergent Adverse Events(Up to 20 days)
- Changes in blood laboratory parameters(Up to 20 days)
- Severity of Treatment Emergent Adverse Events(Up to 20 days)
- Changes in Electrocardiogram (ECG)(Up to 20 days)
研究者
研究点 (2)
Loading locations...
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