Investigation of Pharmacokinetics, Safety, and Tolerability of BAY 63-2521 in Male and Female Subjects With Renal Impairment and in Age- and Weight- Matched Healthy Subjects Following a Single Oral Dose of 1 mg BAY 63-2521 in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 40
- 主要终点
- AUC
研究概览
简要总结
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, 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 1 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Riociguat, healthy participants
Participants with creatinine clearance (CLCR) >80 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat, mild renal impairment
Participants with CLCR 50-80 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat, moderate renal impairment
Participants with CLCR 30-<50 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat, severe renal impairment
Participants with CLCR <30 mL/min received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
结局指标
主要结局
AUC
时间窗: Pre-dose up to 72 hours post-dose
Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
Cmax,u
时间窗: From 2 hours post-dose up to 24 hours post-dose
Cmax for unbound drug for BAY 63-2521 and its metabolite M1
Cmax
时间窗: Pre-dose up to 72 hours post-dose
Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1
t½
时间窗: Pre-dose up to 72 hours post-dose
Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1
AUCu
时间窗: From 2 hours post-dose up to 24 hours post-dose
AUC for unbound drug for BAY 63-2521 and its metabolite M1
fu
时间窗: From 2 hours post-dose up to 24 hours post-dose
Fraction unbound for BAY 63-2521 and its metabolite M1
次要结局
- Cmax/D(Pre-dose up to 72 hours post-dose)
- Cmax,u,norm(From 2 hours post-dose up to 24 hours post-dose)
- CLR(From 24 hours prior to drug administration up to 72 hours post-dose)
- AE,ur(From 24 hours prior to drug administration up to 72 hours post-dose)
- AUCnorm(Pre-dose up to 72 hours post-dose)
- AUCu,norm(From 2 hours post-dose up to 24 hours post-dose)
- tmax(Pre-dose up to 72 hours post-dose)
- MRT(Pre-dose up to 72 hours post-dose)
- CL/F(Pre-dose up to 72 hours post-dose)
- CLu/F(From 2 hours post-dose up to 24 hours post-dose)
- Number of participants with adverse events(Approximately 5 weeks)
- AUC(0-tlast)(Pre-dose up to 72 hours post-dose)
- AUC/D(Pre-dose up to 72 hours post-dose)
- Cmax,norm(Pre-dose up to 72 hours post-dose)
- Vz/F(Pre-dose up to 72 hours post-dose)