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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312973
• Other study ID #: 17767
• Secondary ID: 2014-003292-31
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: January 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2016
• Est. primary completion date: December 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Molidustat(BAY85-3934)
Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
• Molidustat(BAY85-3934)
One single oral dose of 75 mg molidustat in healthy subjects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics characterized by Cmax of Molidustat	Cmax: maximum drug concentration in plasma after single dose administration	Up to 96 hours post dose
Primary	Pharmacokinetics characterized by AUC of Molidustat	AUC: area under the plasma concentration vs time curve from zero to infinity	Up to 96 hours post dose
Primary	Pharmacokinetics characterized by Cmax,norm of Molidustat	Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight	Up to 96 hours post dose
Primary	Pharmacokinetics characterized by (AUCnorm) of Molidustat	AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight	Up to 96 hours post dose
Secondary	Pharmacokinetics characterized by Cmax of erythropoietin	Cmax: maximum drug concentration in plasma after single dose administration	Up to 48 hours post dose
Secondary	Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin	AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification	Up to 48 hours post dose
Secondary	Pharmacokinetics characterized by tmax of erythropoietin	tmax: time to reach maximum drug concentration in plasma after single (first) dose	Up to 48 hours post dose
Secondary	Number of subjects with Treatment Emergent Adverse Event (TEAE)		Up to 7 days post dose