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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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