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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Molidustat(BAY85-3934)
* Drug: Molidustat(BAY85-3934)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively) | Drug: Molidustat(BAY85-3934)<br>* Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis<br>|
| Experimental: Arm 2<br>Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively) | Drug: Molidustat(BAY85-3934)<br>* Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis<br>|
| Experimental: Arm 3<br>Single oral dose of 75 mg molidustat (fasted) in healthy subjects | Drug: Molidustat(BAY85-3934)<br>* One single oral dose of 75 mg molidustat in healthy subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics characterized by Cmax of Molidustat | Cmax: maximum drug concentration in plasma after single dose administration | 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 | 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 | 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 | Up to 96 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics characterized by Cmax of erythropoietin | Cmax: maximum drug concentration in plasma after single dose administration | 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 | 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 | Up to 48 hours post dose | 
| Number of subjects with Treatment Emergent Adverse Event (TEAE) |  | Up to 7 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Chronic kidney disease, Pharmacokinetics, Peritoneal dialysis, Erythropoietin