Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Study Overview
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Brief Summary
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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.

Official Title
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A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation

Conditions
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Anemia

Intervention / Treatment
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* Drug: BAY85-3934
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BAY85-3934<br>* Single doses of 20 mg BAY85-3934 as tablet<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BAY85-3934, pharmacokinetics, age, gender