Anemia
Conditions
Keywords
BAY85-3934, pharmacokinetics, age, gender
Brief summary
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.
Interventions
DRUGBAY85-3934
Single doses of 20 mg BAY85-3934 as tablet
DRUGPlacebo
Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* No diagnosis of any specific disease or condition * Subjects are expected to be in good general health for their respective age range * Male or female gender * Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive) * Racial group: Caucasian
Exclusion criteria
* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease. * Clinically relevant findings in the physical examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours | 96 hours post dose |
| 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 |
| Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours | 48 hours post dose |
Countries
United States
Outcome results
None listed