To investigate pharmacokinetics (absorption, distribution, elimination), safety and tolerability of a single oral dose of 75 mg molidustat tablet in male and female subjects requiring hemo- or peritoneal dialysis compared to healthy subjects
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.
- 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
- 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
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