Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight
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
- Cmax of BAY2327949
研究概览
简要总结
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be ≥18 years of age
- •The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).
- •Race: White
- •BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m*2 at the first screening visit.
- •Male or female.
- •Participants with renal impairment must have an eGFR (estimated glomerular filtration rate) <90 mL/min/1.73 m*2 determined from serum creatinine 21-3 days prior to dosing using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation (eGFR has to be repeated if screening period >10 days before dosing).
- •Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.
排除标准
- •Clinically relevant findings in the physical examination affecting the objectives of the study.
- •Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:
- •Moderate and strong inhibitors of CYP3A;
- •Moderate and strong CYP3A inducers;
- •Moderate and strong inhibitors of P-gp transport;
- •UDP-glucuronosyltransferase (UGT) inhibitors probenecid and valproic acid.
- •Regular daily consumption of more than 10 cigarettes.
- •Acute renal failure.
- •Active nephritis.
- •Impairment of any other major organ system other than the kidney.
- •Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.
研究组 & 干预措施
Participants with moderate renal impairment
干预措施: BAY2327949 (Drug)
Healthy participants
干预措施: BAY2327949 (Drug)
Participants with mild renal impairment
干预措施: BAY2327949 (Drug)
Participants with severe renal impairment
干预措施: BAY2327949 (Drug)
结局指标
主要结局
Cmax of BAY2327949
时间窗: From pre-dose until follow-up (10-12 days after dosing).
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Cmax,u of BAY2327949
时间窗: From pre-dose until follow-up (10-12 days after dosing).
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
AUCu of BAY2327949
时间窗: From pre-dose until follow-up (10-12 days after dosing).
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
AUC of BAY2327949
时间窗: From pre-dose until follow-up (10-12 days after dosing).
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
次要结局
- Urinary volume(From Day -1 until Day 4 (72h after dosing))
- Fluid balance(From Day -1 until Day 4 (72h after dosing))
- Frequency and nature of treatment-emergent adverse events(Approximate 14 days (from starting treatment to end of follow-up))