Trial Condition(s):

Renal Insufficiency, Chronic

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

Bayer Identifier:

17767

ClinicalTrials.gov Identifier:

NCT02312973

EudraCT Number:

2014-003292-31

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
40
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 
Locations

Investigative Site

Velbert, Germany, 42549

Status
Completed
 

Trial Design