An Open-label Study to Evaluate the Pharmacokinetics and Safety of BAY 1817080 in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- AUCu after single dose of BAY1817080
研究概览
简要总结
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
- •For renally impaired participants:
- •Decreased renal function, as assessed based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m^2; or ESRD on dialysis.
- •Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening.
- •For participants with normal renal function:
- •- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI : eGFR ≥90 mL/min/1.73 m^
- •Body mass index (BMI) within the range 18 to 38 kg/m^2 (both inclusive)
- •Women of childbearing potential (WOCBP) must agree to use contraception for the duration of the study. This applies for the time period between signing of the Informed Consent Form until at least 30 days after the last dose of the study drug.
- •Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.
- •Acute renal failure or acute nephritis within the past 2 years
- •Use of strong CYP3A4 and P-glycoprotein inhibitors from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
- •Use of CYP3A4 and P-glycoprotein inducers from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
- •Use of drugs which may affect absorption (e.g. loperamide, metoclopramide), and systemic administration of any broad-spectrum antibiotic within 1 week before first study drug administration, unless the drug is part of the mandatory dosing regimen for treatment of renal impairment or related conditions.
- •International Normalized Ratio (INR) > 2.
- •Indication or evidence for long QT syndrome; Participants in control group only: QT interval corrected using Fridericia's method (QTcF) > 450 msec.
- •Inability to provide informed consent: Participants with psychiatric disorders.
研究组 & 干预措施
Arm A: Moderately impaired renal function
Participants with moderately impaired renal function will receive multiple doses of BAY1817080.
干预措施: BAY1817080 (Drug)
Arm B: Normal renal function matched to Arm A
Participants with normal renal function matched to Arm A will receive multiple doses of BAY1817080.
干预措施: BAY1817080 (Drug)
Arm C: End stage renal disease on dialysis
Participants with ESRD requiring dialysis will receive single dose of BAY1817080.
干预措施: BAY1817080 (Drug)
Arm D: Normal renal function matched to Arm C
Participants with normal renal function matched to Arm C will receive single dose of BAY1817080.
干预措施: BAY1817080 (Drug)
结局指标
主要结局
AUCu after single dose of BAY1817080
时间窗: On Day 1
AUCu: Area under the Curve unbound
Cmax,u after single dose of BAY1817080
时间窗: On Day 1
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
次要结局
- Number of subjects with treatment emergent adverse events (TEAEs)(From dosing up to 14 days after end of treatment with study medication)
- AUC (0-12)md,u after multiple dose of BAY1817080(From Day 6 to Day 13)
- Cmax,md,u after multiple dose of BAY1817080(From Day 6 to Day 13)