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Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY85-3934 | Drug | Single doses of 20 mg BAY85-3934 as tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934 | Measured over 72 hours after dosing | |
| Maximum drug concentration in plasma after single dose administration of BAY85-3934 | Measured over 72 hours after dosing | |
| Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline) | Measured over 96 hours after dosing | |
| Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event) | Measured over 96 hours after dosing | |
| Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline) | Measured over 72 hours after dosing | |
| Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline) | Measured over 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours | 48 hours post dose | |
| Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours | 96 hours post dose |
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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 |
|---|---|---|---|---|---|---|
| Fargo | North Dakota | 58104 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| Drug |
Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet |
|
| Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours | 48 hours post dose |
| Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours | 96 hours post dose |
| Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours | 96 hours post dose |