Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR 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 (first) dose (AUC) of BAY1142524
研究概览
简要总结
The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
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
- •Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
- •Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
- •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.
- •Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).
排除标准
- •Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
- •Relevant impairment in liver function.
- •Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- •Any organ transplant < 1 year before participation in this study.
- •Subject under dialysis or planned to start dialysis during participation in the study.
- •Failure of any other major organ system other than the kidney.
研究组 & 干预措施
Normal (healthy subjects)
Healthy subjects matched for age, body weight and gender to the groups with renal impairment
干预措施: Fulacimstat (BAY1142524) (Drug)
Mildly renal impaired
Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2
干预措施: Fulacimstat (BAY1142524) (Drug)
Moderately renal impaired
Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2
干预措施: Fulacimstat (BAY1142524) (Drug)
Severely renal impaired
Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2
干预措施: Fulacimstat (BAY1142524) (Drug)
结局指标
主要结局
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524
时间窗: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524
时间窗: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC of unbound drug (AUCu) of BAY1142524
时间窗: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC (0-tlast) u will be used if mean AUC (tlast ∞) \>20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
Cmax of unbound drug (Cmax,u) of BAY1142524
时间窗: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
An additional blood sample for fu will be collected at 2 hours after dosing.
次要结局
- Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability(up to 10 days after dosing)