Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of 25 mg BAY 2433334 in Male and Female Participants With Different Stages of Renal Impairment (Including on Dialysis), as Compared to Age, Gender and Weight Matched Participants in a Single-center, Non-randomized, Non-controlled, Non-blinded, Group Stratification Design Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the blood stream to plug another vessel. Renal impairment which co-occurs in elderly and patients with heart attack, irregular heart beat or stroke is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of BAY2433334, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 25 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants: ≥18 years, male or female (non-WOCBP only), BMI 18-35 kg/m² (inclusive); no increased risk of bleeding or common causes of bleeding, no liver dysfunction; no CYP3A4 inhibitors/inducers;
- •Participants with reduced kidney function including those on kidney replacement therapy ("dialysis"): stable disease stratified by renal function (mild, moderate, severe, ESRD), no recent cardiovascular events;
- •Age-, gender- and weight-matched participants: normal kidney function, stable and well controlled hypertension and dyslipidemia acceptable, no medications influencing the coagulation system.
排除标准
- •Subjects with renal impairment
- •Acute renal failure or active nephritis.
- •Known impaired hepatic function.
- •History of definite myocardial infarction or cerebrovascular accident within the six months prior to the screening visit.
- •History of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing.
- •Congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring antiarrhythmic treatment.
- •Any other disease or condition which could influence the physiological metabolic turnover (e.g., endocrine diseases, severe infections).
- •Age-, gender, weight matched subjects
- •History of relevant diseases of vital organs or systems (e.g., of the central nervous system or other systems or organs) with the exception of mild, well controlled hypertension, dyslipoproteinemia and thyroid disorders.
研究组 & 干预措施
Experimental: Treatment 1
Participants in Groups 1-4 and Group 6 will receive a single dose of BAY2433334 on one occasion. Participants in Group 5 will receive a single dose of BAY2433334 on a dialysis-free day.
干预措施: BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5 (Drug)
Experimental: Treatment 2
Participants in Group 5 will receive a single dose of BAY2433334 on a day with dialysis treatment.
干预措施: BAY2433334 on dialysis treatment day (Other)
结局指标
主要结局
Cmax
时间窗: Pre-dose until 96 hours after dosing
maximum observed drug concentration in measured matrix after single dose administration
AUC
时间窗: Pre-dose until 96 hours after dosing
area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Cmax,u
时间窗: Pre-dose until 96 hours after dosing
maximum unbound drug concentration in plasma after single dose administration
AUCu
时间窗: Pre-dose until 96 hours after dosing
area under the unbound plasma concentration vs time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
次要结局
- Number of participants with treatment emergent adverse events (TEAEs)(Up to 3 days after last study medication)