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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Molidustat(BAY85-3934)	Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
DRUG	Molidustat(BAY85-3934)	One single oral dose of 75 mg molidustat in healthy subjects

Timeline

• Start date: 2015-01-14
• Primary completion: 2015-12-02
• Completion: 2016-06-01
• First posted: 2014-12-09
• Last updated: 2021-01-25

Locations

2 sites across 1 country: Germany