Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Renal Insufficiency, Chronic
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02312973
Start Date
January 14 2015
End Date
June 1 2016
Last Update
January 25 2021
Active Locations (2)
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1
Velbert, North Rhine-Westphalia, Germany, 42549
2
Kiel, Schleswig-Holstein, Germany, 24105