Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded 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
- Pharmacokinetics characterized by Cmax of Molidustat
研究概览
简要总结
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Male and female (without childbearing potential)
- •Age: ≥18 and ≤79 years of age
- •Body mass index (BMI): ≥18 and ≤34 kg/m2
- •Ethnicity: White
- •Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and
- •Healthy subjects
排除标准
- •Women of childbearing potential, pregnant or lactating women
- •Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- •Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab)
- •Exclusion periods from other studies or simultaneous participation in other clinical studies
研究组 & 干预措施
Arm 1
Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)
干预措施: Molidustat(BAY85-3934) (Drug)
Arm 2
Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively)
干预措施: Molidustat(BAY85-3934) (Drug)
Arm 3
Single oral dose of 75 mg molidustat (fasted) in healthy subjects
干预措施: Molidustat(BAY85-3934) (Drug)
结局指标
主要结局
Pharmacokinetics characterized by Cmax of Molidustat
时间窗: Up to 96 hours post dose
Cmax: maximum drug concentration in plasma after single dose administration
Pharmacokinetics characterized by AUC of Molidustat
时间窗: Up to 96 hours post dose
AUC: area under the plasma concentration vs time curve from zero to infinity
Pharmacokinetics characterized by Cmax,norm of Molidustat
时间窗: Up to 96 hours post dose
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
Pharmacokinetics characterized by (AUCnorm) of Molidustat
时间窗: Up to 96 hours post dose
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
次要结局
- Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin(Up to 48 hours post dose)
- Pharmacokinetics characterized by tmax of erythropoietin(Up to 48 hours post dose)
- Pharmacokinetics characterized by Cmax of erythropoietin(Up to 48 hours post dose)
- Number of subjects with Treatment Emergent Adverse Event (TEAE)(Up to 7 days post dose)