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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003292-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively) |
|
| Arm 2 | Experimental | 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) |
|
| Arm 3 | Experimental | Single oral dose of 75 mg molidustat (fasted) in healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molidustat(BAY85-3934) | Drug | Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velbert | North Rhine-Westphalia | 42549 | Germany | |||
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| Molidustat(BAY85-3934) | Drug | One single oral dose of 75 mg molidustat in healthy subjects |
|
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 |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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