drugset / Trial / NCT02312973

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

NCT02312973

Phase 1 Completed 40 enrolled Bayer
Non-randomizedCrossoverOpen-labelOther

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.

Timeline

Start
2015-01-14
Primary completion
2015-12-02
Completion
2016-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Molidustat Small molecule 75 mg Oral