Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design
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
- 1
- 主要终点
- Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
研究概览
简要总结
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.
- •Age: 18 to 79 years (inclusive) at the screening visit.
- •Body mass index (BMI): 18 to 34 kg/m² (both inclusive).
- •Male or female subject.
- •Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).
- •Subjects with renal impairment:
- •eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.
- •Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- •Healthy subjects:
- •eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.
排除标准
- •Pregnant or lactating women.
- •Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
研究组 & 干预措施
Subjects with moderate renal impairment
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
干预措施: BAY1101042 (Drug)
Subjects with mild renal impairment
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
干预措施: BAY1101042 (Drug)
Subjects with severe renal impairment
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
干预措施: BAY1101042 (Drug)
Matched healthy subject group
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
干预措施: BAY1101042 (Drug)
结局指标
主要结局
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
时间窗: Study Day 1 to Study Day 6
Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
AUCu of BAY1101042
时间窗: Study Day 1 to Study Day 6
Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Cmax,u of BAY1101042
时间窗: Study Day 1 to Study Day 6
Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
时间窗: Study Day 1 to Study Day 6
Maximum observed concentration of BAY1101042 in plasma after single dose administration
次要结局
未报告次要终点