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

Bayer40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Renal Insufficiency, Chronic

Interventions

Molidustat(BAY85-3934)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetics characterized by Cmax of Molidustat

Cmax: maximum drug concentration in plasma after single dose administration

Time frame: Up to 96 hours post dose

Pharmacokinetics characterized by AUC of Molidustat

AUC: area under the plasma concentration vs time curve from zero to infinity

Time frame: Up to 96 hours post dose

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

Time frame: Up to 96 hours post dose

Pharmacokinetics characterized by (AUCnorm) of Molidustat

AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight

Time frame: Up to 96 hours post dose

Secondary Outcomes

Pharmacokinetics characterized by Cmax of erythropoietin

Cmax: maximum drug concentration in plasma after single dose administration

Time frame: Up to 48 hours post dose

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

Time frame: Up to 48 hours post dose

Pharmacokinetics characterized by tmax of erythropoietin

tmax: time to reach maximum drug concentration in plasma after single (first) dose

Time frame: Up to 48 hours post dose

Number of subjects with Treatment Emergent Adverse Event (TEAE)

Time frame: Up to 7 days post dose

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes